Sativex®

Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose oro-mucosal spray; each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials.  The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.

For more details on GW Pharmaceuticals, the makers of Sativex® and to contact them with any queries you may have in Canada  please visit their website  - GW Pharmaceuticals

For any queries with regards Sativex® in the UK please contact Bayer Healthcare, GW’s marketing partner for the UK.

There is no strong evidence to back the use of cannabis extract in the treatment of Multiple Sclerosis (MS), concludes a review of the available evidence on the first licensed preparation, published in the December issue of Drug and Therapeutics Bulletin (DTB).

Sativex, in the form of a mouth spray, contains the principal extracts—dronabinol and cannabidiol—found in the leaf and flower of the cannabis plant. It is the first cannabinoid preparation to be licensed for use in the treatment of muscle spasms in MS.

MS is estimated to affect around 100,000 people in the UK, and around one in every 1000 people will develop the condition in the UK.

An increase in muscle tone, or spasticity is a common symptom of the condition, causing involuntary spasms, immobility, disturbed sleep, and pain.

Complex combinations of drugs are sometimes needed to manage spasticity, but they don't work that well and have a range of unpleasant side effects.

Sativex is intended for use as a second line treatment in patients in whom these other options have failed. But the DTB review found that the trial data on which the success of Sativex is based, are limited.

Overall, the trials, on which the drug's approval was based, did show a small difference in the numbers of patients who in whom symptoms abated compared with those taking a dummy (placebo) preparation.

But in many of these studies, Sativex was used for relatively short periods—from six weeks to four months. And none included an active ingredient with which the effects of Sativex could be compared.

Two of the trials included doses that exceeded the 12 daily sprays for which the preparation is licensed. One trial did not have sufficient numbers of participants to validate the results.

A third trial, which was properly designed, and did have sufficient numbers of participants, did not find any significant difference in symptom relief between those who took Sativex and those who didn't.

The preparation is also expensive, notes DTB, and costs around 10 times as much as other drugs used for the secondary treatment of MS muscle spasms.

As yet, the body that advised the NHS on its use of treatments, the National Institute for Health and Clinical Excellence (NICE) has not offered any advice on the use of cannabis extract either, although it is set to do so.

But the DTB review says that the strength of the evidence is insufficient to warrant its routine use. "We believe that such limitations make it difficult to identify the place of this product in clinical practice," it concludes. Commenting on the review, GP and DTB editor, James Cave, said the findings of the review were "disappointing."

"MS is a serious and disabling condition, and it would be great to say that this drug could make a big difference, but the benefit is only modest," he said.

Source: BMJ-British Medical Journal & Science Codex (13/12/12)

Almirall S.A. announced that results of the MObility ImproVEments with Spasticity in Multiple Sclerosis (MOVE) 2 observational study performed in Germany, with 300 patients, showed that one month's treatment with Sativex®(THC:CBD) oromucosal spray reduces moderate to severe multiple sclerosis spasticity (MSS) by 20% or more in 4 out of 10 patients previously unresponsive to conventional therapies. After three months, the improvement observed was 30% or more. Overall, 55% of the initial patients were eligible for continuing treatment beyond the third month.

This prospective, observational study is presented today at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France.

"An improvement on the numerical rating scale (NRS) of at least 30% after 3 months is considered clinically relevant. For patients, it translates into less disturbed sleep due to MSS spasms, less pain, improved bladder function and a greater ability to perform simple daily activities involving mobility. These findings from everyday clinical practice are aligned or superior to those reported in previous clinical trials with Sativex®, and were achieved with slightly fewer average daily doses," commented MOVE 2 lead investigator Professor Peter Flachenecker, Neurological Rehabilitation Centre Quellenhof, Bad Wildbad, Germany.

The MOVE 2 is a multicentre, prospective, observational study including 300 adults with moderate to severe MSS treated in 42 specialised MS centres throughout Germany. Mean MS spasticity NRS scores decreased by 25% compared to pre-treatment with Sativex®, with 41% of patients improving at least 30% from baseline (from 6.7 to 3.2 in this subgroup; p<0.0001). Quality of life measurements (MS QoL-54 scale) also improved from baseline in the third month's visit (p<0.01).

Sativex® was generally well tolerated. Adverse events were reported in 16.6% of the treated patients, being the most common ones dizziness, fatigue or drowsiness mostly transient and mild or moderate in intensity.

Other new data from Sativex®' ongoing registries in the UK (n=493, retrospective data collection, 18 months mean exposure) and Spain (n=103, 6 months prospective follow-up) which are being presented in this congress, further support these findings.

On top of the clinical relevance demonstrated in the MOVE 2, a recent publication from J. Slof shows that Sativex® is a cost effective treatment. In a Markov model from the German healthcare payer perspective, the incremental cost effectiveness ratio for Sativex® was €10,809. This is well below commonly accepted thresholds for cost effectiveness, such as the £30,000 (€38,000) specified by the UK National Institute for Health and Clinical Excellence (NICE).

In Europe, Sativex® is commercialised for the treatment of MS spasticity in the UK, Spain, Germany and Denmark. Launches are also currently in preparation in Italy, Austria, Iceland and Norway. In addition, regulatory authorization has been also received in Belgium, Sweden, the Netherlands, Portugal, Czech Republic and Slovakia with launches expected from the end of 2012 onwards.

In addition to MS spasticity, Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.

Source: GW Pharmaceuticals plc (12/10/12)

An extract from the plant Cannabis sativa (trade name Sativex®) was approved in May 2011 for patients suffering from moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS). In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new drug, which is used as a mouth spray, offers an added benefit over the optimized standard therapy.

However, no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.

Comparison of different possibilities for optimizing treatment

The extract from Cannabis sativa, which contains the active ingredient combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), is approved as add-on therapy to the already used antispastic drugs. Usually, drugs such as baclofen or tizanidine are given to treat muscle spasms. The cannabis extract can be considered when, despite an individual, patient-tailored use of these drugs, the symptoms caused by spasticity cannot be adequately relieved.

The G-BA specified an optimized standard therapy containing baclofen, tizanidine or drugs that are approved for the treatment of spasticity in underlying neurological diseases as the appropriate comparator therapy. At least two previous attempts at treatment were to have been made, in each of which different oral antispastic (spasmolytic) drugs had been used in an optimum way. Again, at least one product was to have contained the active ingredients baclofen or tizanidine. The aim of the assessment by IQWiG was to compare the additional administration of the Cannabis sativa extract with other available possibilities for optimizing treatment and to assess the added benefit.

Optimization of premedication was not planned in any of the studies

However the manufacturer deviated from this specification of the G-BA, without providing adequate justification for doing so. In its dossier, the manufacturer drew no conclusions about the extent and probability of the added benefit compared to the appropriate comparator therapy specified by the G-BA. The studies submitted by the manufacturer were not suitable for reaching conclusions on added benefit in comparison with an optimized standard therapy. This was because in none of these studies was it planned to optimize the antispastic premedication. Instead, this treatment was to be continued unchanged. Therefore there is no proof from the manufacturer's dossier of an added benefit of Cannabis sativa extract compared to the appropriate comparator therapy of the G-BA.

Source: Medical News Today MediLexicon International Ltd © 2004-2012 (20/09/12)

Post Script 27/11/12

In June this year, a resolution of the German Federal Joint Committee (G-BA) on the early evaluation of benefits for Sativex was positive. The G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The G-BA determined that there was an indication of minor added benefit of Sativex® as an add-on therapy in MS-induced spasticity. This was in contrast to the previous evaluation by the IQWiG that had certified no additional benefit for technical reasons. The G-BA has now confirmed this position and certified an additional benefit to Sativex’s use in MS Spasticity management.

Summary: This new study from a research group in Scotland assesses the long term safety profile of regular Sativex use for spasticity in MS.

The report, which follows-up 146 patients using treatment for a mean duration of 334 days, administering a mean of 7.3 actuations per day, found that 36% withdrew in the first year, either due to adverse events of lack of efficacy. Most common adverse events were fatigue and dizziness. Serious adverse events were rare and included two psychiatric events in the same patient. No serious effects were seen with abrupt withdrawal and patients did not build up a tolerance to the drug in this study.

Abstract
Sativex is an endocannabinoid system modulator principally containing Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD). During a 6-week randomised controlled trial, Sativex had a clinically relevant effect on spasticity associated with multiple sclerosis (MS).

Patients self-titrated oromucosal Sativex to symptom relief or maximum tolerated dose (maximum of 130 mg THC and 120 mg CBD daily).

The primary objective was to evaluate the safety and tolerability of long-term treatment by recording the incidence and severity of adverse events (AEs).

Secondary outcomes were to determine evidence of developing tolerance and to assess the long-term dosing profile of Sativex.

A validated 11-point Numerical Rating Scale of spasticity severity was used to assess efficacy. A total of 146 patients elected to enter this open-label follow-up safety trial.

Mean treatment exposure was 334 days (standard deviation, SD = 209 days), and patients administered on average 7.3 (SD = 4.42) actuations per day.

Fifty-two (36 %) patients withdrew from the study in the first year, 14 % due to AEs and 9 % due to lack of efficacy. Most AEs were mild/moderate in severity. Common (>10 %) treatment-related AEs were dizziness (24.7 %) and fatigue (12.3 %).

Serious AEs occurred in five patients (3.4 %), with two psychiatric events reported by one patient.

No psychoses, psychiatric AE trends, or withdrawal symptoms occurred following abrupt cessation of treatment.

Baseline symptoms including spasticity did not deteriorate but were maintained to study completion in those patients who did not withdraw. No new safety concerns were identified with chronic Sativex treatment, and serious AEs were uncommon.

There was no evidence of tolerance developing, and patients who remained in the study reported continued benefit.

Serpell MG, Notcutt W, Collin C.

Pain Clinic, Division of Developmental Medicine, Department of Anaesthetics, Gartnavel General Hospital, University of Glasgow, Glasgow, UK

Source: J Neurol. 2012 Aug 10 & Pubmed PMID: 22878432 (14/08/12)

Efforts at making a medication derived from cannabis available for persons with Multiple Sclerosis have moved a step closer, with the completion of the European Mutual Recognition Procedure.

Galway West Deputy Seán Kyne confirmed the news this week, saying that he had a number of representations made to him by constituents concerned at the lack of availability in Ireland of Sativex, a cannabis-derived medication which has been shown to successfully alleviate some of the debilitating symptoms of MS.

“Sativex is available in Britain and the US and has been very successful in assisting people with MS. I first raised the issue of its availability here with the Minister when several constituents contacted me who either have MS or have relatives or friends with the condition.

“Since last September, Minister Reilly and his Department have been examining how to proceed with introducing such a medication that requires the amendment of the Misuse of Drugs Act 1977 which rightly prohibits the manufacture, production, preparation, sale, supply, distribution and possession of cannabis but unfortunately also prohibits cannabis-based medicinal products.”

Deputy Kyne continued to add that the European Commission had been running a European Mutual Recognition Procedure for the drug, alongside the the Department of Health review.

The European Mutual Recognition Procedure was introduced with the 2001 Directive on the Community Code Relating to Medicinal Products for Human Use and aims to ensure agreement on the use of a medicinal product that has been introduced in at least one member state of the EU.

“With the successful conclusion of the procedure, the manufacturer of Sativex, GW Pharma, has committed to working on the wording, packaging and pricing of the medication for introduction in other member states,” explained Deputy Kyne.

“I’m confident that the European efforts, alongside the review underway at the Irish Department of Health, will soon see the introduction of Sativex on the Irish market to the benefit of people in Ireland with MS.”

Source: Galway Independent Copyright © 2007 - 2012 | Powered by iMedia Revenue Ltd (21/05/12)

GW Pharmaceuticals plc and Almirall S.A. today announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex® oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).

Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex® to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex® meets their requirements for approval. The countries involved in the MRP and in which Sativex® is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.

"For Almirall, the successful completion of this second MRP regulatory process for Sativex® represents very good news and reinforces our commitment to expand this innovative medicine to MS patients across Europe. Sativex® is the first treatment specifically indicated for the treatment of spasticity, and related symptoms, in MS patients" said Bertil Lindmark, Chief Scientific Officer at Almirall.

The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, each country is then expected to issue a national marketing authorisation. Launch timing in these ten new countries is dependent on national pricing and reimbursement procedures. Launches are anticipated from the end of 2012 onwards.

Dr Stephen Wright, GW's R&D Director, said, "Today's news means that regulatory authorities in a total of eighteen European countries have now recommended Sativex® for approval. The successful outcome of this most recent regulatory process provides further endorsement of the quality, safety and efficacy of Sativex®. Sativex® has an important role in meeting the needs of people with Multiple Sclerosis and we look forward to working with our partners Almirall to make the medicine available to patients across Europe."

In Europe, Sativex® is approved and marketed for MS spasticity in the UK, Spain, Germany, and Denmark. In addition to the ten new European markets included in this MRP, launches are also currently being planned in Sweden, Italy, Austria and the Czech Republic.

In addition to MS spasticity, Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.

Source: GW Pharmaceuticals plc (08/05/12)

GW Pharmaceuticals plc (AIM: GWP) announces that it has signed an amendment to its Sativex® licence agreement with Almirall S.A. As part of the revised agreement, Almirall has been granted rights to market Sativex® in Mexico and GW will receive a new near term milestone payment of €12 million (£10 million).

Under the terms of the original licence agreement signed in December 2005, Almirall was granted exclusive rights to market Sativex® in Europe (excluding the UK). With Sativex® now approved and launched by Almirall in certain European countries and with further launches planned, GW and Almirall have revisited the financial terms in order to optimise the agreement to best suit the current strategic interests of both companies.

In return for Almirall agreeing to pay to GW a new milestone payment of €12m (£10m) based on a near term cancer pain trial recruitment target, GW has agreed to reduce the Sativex® supply price charged by GW to Almirall over the next few years until the launch of Sativex® in the cancer pain indication in Europe and has agreed to cancel future cancer pain launch milestones of £5.5m. In addition, Almirall has been granted exclusive rights to commercialise Sativex® in Mexico, a country in which Almirall has had an affiliate in place for more than a decade.

Luciano Conde, Chief Operating Officer of Almirall, said "We have been very pleased with our partnership with GW and the initial market response to Sativex®. Sativex® is a new therapeutic option to alleviate suffering from the physical impairment caused by muscle spasticity and Almirall has been committed to ensuring its availability across Europe and now also in Mexico."

Justin Gover, Managing Director of GW, said "We are delighted to expand our long term relationship with Almirall. We have been impressed with their commitment to the product and pleased with their success to date. The new near term milestone payment will further strengthen our balance sheet at a time when we are supporting multiple European Sativex® launches as well as planning to expand manufacturing for the United States market and for the future cancer pain indication. A further consequence of this new near term milestone payment is that GW now expects to report a small profit in the current financial year ending 30 September 2012."

Sativex® is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic. In addition, a Mutual Recognition Procedure (MRP) regulatory filing is currently underway to expand Sativex® approvals to ten additional European countries. It is expected that this new MRP process should complete around mid 2012.

Sativex® is approved as a treatment for spasticity in people with Multiple Sclerosis. The product is also in Phase III clinical development as a treatment for cancer pain.

Source: GW Pharmaceuticals (15/03/12)

Cannabis-based medicinal products, such as Sativex, could soon be available to sufferers of Multiple Sclerosis (MS) and other medical conditions on prescription.

This follows confirmation by the Minister for State at the Department of Health, Róisín Shortall, that the department “is examining the issues associated with applying controls, similar to those that apply to other controlled drugs that can be misused, such as morphine and methadone, to cannabis-based medicinal products to permit them to be prescribed and dispensed in Ireland.”

In a written response to a Dáil question tabled by Luke Flanagan, Ms Shortall said: “I am aware that claims have been made in respect of the possible health benefits of cannabis-based medicinal products for patients suffering from certain conditions such as MS.

“I am also aware that Sativex [manufactured by UK-based pharma company, GW Pharmaceuticals] is authorised in the UK for the relief of spasm in patients with MS,” Ms Shortall added.

Mr Flanagan described the current Government policy of prohibiting the supply of cannabis-based medicinal products as “heartless and cruel”.

He said Ms Shortall’s response “gives room for hope” to sufferers of conditions such as MS.

“I received a letter from one person who purchased Sativex in the North. The Sativex dealt with the person’s incontinence and the patient didn’t have to use a nappy while on the medication, but is now back wearing a nappy because this person can’t buy Sativex in the Republic,” he said.

The chairman of the Irish Patients’ Association, Stephen McMahon, last night welcomed the Minister’s statement that the Government is considering allowing Sativex to be prescribed.

Source: Irish Times © 2012 irishtimes.com (21/02/12)

Desperate multiple sclerosis patient Kiran Narang says it is criminal she is denied access to cannabis-based drug Sativex, while others are prescribed it.

NHS Calderdale’s policy is to deny patients Sativex but last week the Courier revealed how one doctors’ surgery was flouting those rules and had prescribed it 19 times in six months.

The drug – a mouth spray – contains cannabinoids, extracted from cannabis plants, which can help relieve the painful muscle spasms MS causes.

MS sufferer Kiran Narang, 52, of Bankfoot Terrace, Hebden Bridge, says she is desperate for the drug as she believes it would improve her quality of life.

“The pain is constant – nagging – which in itself can be exhausting. You can’t sleep. It’s impossible.

“It’s like a having a permanent cramp.

“I have been told by my GP that she would love to prescribe me Sativex but is not able to.

“The fact that Sativex is being denied for the majority of people seems almost criminal.

“It’s forcing people with MS to be criminals because the only way to get cannabis would mean people having to use the black market.

“It might keep the cost of the NHS down but it’s certainly not helping the people it’s meant to be helping.

“Congratulations to the doctor for taking that risk.

“I think it’s brilliant because it is a doctor actually saying that there’s a need and knowing what can be done.

“I do think it takes a lot of courage to do something like that – which is unfortunate.

“But it’s for GPs to be arguing.

“There are enough people that feel Sativex would be of real, substantial use to them but are told the same thing, except for these lucky people who are getting it. It shows it can be done.”

Sativex was approved by the Department of Health and licensed in the UK in 2012.

It costs £125 for a 10ml vial – about £11 per day per patient. NHS Calderdale rejected the drug on advice from the Yorkshire and Humber Specialised Commissioning Board, ruling it would not be routinely funded for Calderdale’s estimated 300 sufferers.

The health trust last week told the Courier its policy had not changed.

Source: Halifax Courier © 2012 Johnston Publishing Ltd. (13/02/12)

Medicinal cannabis is now available as a prescription medicine in Sweden after the Medical Products Agency (Läkemedelsverket) approved a cannabis-based mouth spray for the treatment of multiple sclerosis (MS).

"This is great news for those who can't get any relief from the most common drugs," said Jan Hillert, an MS researcher at Karolinska Institutet, to the Dagens Nyheter daily.

The agency has said that it plans to closely monitor the prescription of the new drug to ensure against abuse.

According to the agency however, the spray does not give any sort of "kick" as the cannabis content is in such small doses and common side effects include dizziness, nausea and drowsiness.

People suffering from MS, which damages the brain and the central nervous system, often experience problems with stiffness and muscle cramps.

The spray, which is used under the tongue, has been proved to be successful in alleviating MS symptoms by a series of medical studies.

The cannabis spray, Sativex, is already available in the UK and Spain. Earlier this year it was approved by agencies in Germany and Denmark.

It is not strictly illegal today to prescribe medicinal cannabis in Sweden but it is a lengthy and complicated process.

The doctor has to apply for a special permit from the Medical Products Agency and if approved the closest pharmacy has to arrange a special import.

Source: The Local © The Local Europe AB 2012 (13/02/12)

GW Pharmaceuticals plc (AIM: GWP) today announces a regulatory update for Sativex® (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)) oromucosal spray.

Sativex® has received regulatory approval in Austria as a treatment of spasticity due to Multiple Sclerosis (MS). The launch of Sativex® in Austria is expected to take place during 2012 following completion of the national pricing and reimbursement process. Sativex® will be marketed in Austria by GW's marketing partner, Almirall S.A.

In addition, further to the November 2011 announcement of the filing of a new regulatory application, under the European Mutual Recognition Procedure (MRP), to expand Sativex® approvals to additional European countries, the dossier has been validated and is now under technical review by regulatory authorities in the following countries: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. It is expected that this new MRP process should complete around mid 2012.

Sativex® is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic.

Sativex® has been developed by GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall.The product is also in Phase III clinical development as a treatment for cancer pain.

Source: GW Pharmaceuticals plc (07/02/12)

A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents — a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis.

FDA approval would represent an important milestone in the nation's often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors' recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug could increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma's footsteps.

"There is a real disconnect between what the public seems to be demanding and what the states have pushed for and what the market is providing," said Aron Lichtman, a Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society. "It seems to me a company with a great deal of vision would say, 'If there is this demand and need, we could develop a drug that will help people and we will make a lot of money.'"

Possessing marijuana still is illegal in the United Kingdom, but about a decade ago GW Pharma's founder, Dr. Geoffrey Guy, received permission to grow it to develop a prescription drug. Guy proposed the idea at a scientific conference that heard anecdotal evidence that pot provides relief to multiple sclerosis patients, and the British government welcomed it as a potential way "to draw a clear line between recreational and medicinal use," company spokesman Mark Rogerson said.

In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations.

"We were the first ones to charge forward and a lot of people were watching to see what happened to us," Rogerson said. "I think we are clearly past that stage."

In 1985, the FDA approved two drug capsules containing synthetic THC, Marinol and Cesamet, to ease side-effects of chemotherapy in cancer patients. The agency eventually allowed Marinol to be prescribed to stimulate the appetites of AIDS patients. The drug's patent expired last year, and other U.S. companies have been developing formulations that could be administered through dissolving pills, creams and skin patches and perhaps be used for other ailments.

Doctors and multiple sclerosis patients are cautiously optimistic about Sativex. The National Multiple Sclerosis Society has not endorsed marijuana use by patients, but the organization is sponsoring a study by a University of California, Davis neurologist to determine how smoking marijuana compares to Marinol in addressing painful muscle spasms.

"The cannabinoids and marijuana will, eventually, likely be part of the clinician's armamentarium, if they are shown to be clinically beneficial," said Timothy Coetzee, the society's chief research officer. "The big unknown in my mind is whether they are clearly beneficial."

Opponents and supporters of crude marijuana's effectiveness generally agree that more research is needed. And marijuana advocates fear that the government will use any new prescription products to justify a continued prohibition on marijuana use.

"To the extent that companies can produce effective medication that utilizes the components of the plant, that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," Americans for Safe Access spokesman Kris Hermes said. "That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill."

Interest in new and better marijuana-based medicines has been building since the discovery in the late 1980s and 1990s that mammals have receptors in their central nervous systems, several organs and immune systems for the chemicals in botanical cannabis and that their bodies also produce natural cannabinoids that work on the same receptors.

One of the first drugs to build on those breakthroughs was an anti-obesity medication that blocked the same chemical receptors that trigger the munchies in pot smokers. Under the name Acomplia, it was approved throughout Europe and heralded as a possible new treatment for smoking cessation and metabolic disorders that can lead to heart attacks.

The FDA was reviewing its safety as a diet drug when follow-up studies showed that people taking the drug were at heightened risk of suicide and other psychiatric disorders. French manufacturer Sanofi-Aventis, pulled it from the market in late 2008.

Given that drug companies already were reluctant "to touch anything that is THC-like with a 10-foot- pole," the setback had a chilling effect on cannabinoid drug development, according to Lichtman.

"Big companies like Merck and Pfizer were developing their own versions (of Acomplia), so all of those programs they spent millions and millions on just went away..." he said.

But scientists and drug companies that are exploring pot's promise predict the path will ultimately be successful, if long and littered with setbacks.

One is Alexandros Makriyannis, director of the Center for Drug Discovery at Northeastern University and founder of a small Boston company that hopes to market synthetic pain products that are chemically unrelated to marijuana, but work similarly on the body or inhibit the cannabinoid receptors. He also has been working on a compound that functions like the failed Acomplia but without the depressive effects.

"I think within five to 10 years, we should get something," Makriyannis said.

Source: Fox News.com ©2012 FOX News Network (23/01/12)

GW Pharmaceuticals plc today announced that the Medical Products Agency in Sweden has granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as a treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medicationi. Sativex® is a first in class endocannabinoid system modulator and is currently available in the UK, Germany, Spain and Denmark.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activities.

The launch of Sativex® in Sweden is expected to take place during the first half of 2012 following completion of the national pricing and reimbursement process. Sativex® will be marketed in Sweden by GW's marketing partner, Almirall S.A.

Justin Gover, GW's Managing Director, said, "We are very pleased to announce the approval of Sativex® in Sweden. Sativex® addresses a significant unmet need for people with multiple sclerosis and we look forward to the launch of this important medicine in Sweden next year."

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals (22/12/11)

GW Pharmaceuticals plc today announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) to seek to expand the marketing authorization for Sativex® to a number of additional European member states.

The new MRP follows successful completion of a previous MRP earlier this year in which recommendation for approval of Sativex® was obtained from regulatory authorities in Germany, Italy, Denmark, Sweden, Austria and the Czech Republic. Prior to this, Sativex® received approval in 2010 in the UK and Spain.

The complete list of countries to which the MRP application is being made is currently being finalised. The list is expected to include approximately ten new countries and will mean that if this MRP process is successful, approaching twenty European countries will have recommended approval of Sativex.

It is expected that this new MRP process should complete around mid 2012.

As with the previous MRP, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State for the purposes of this new MRP procedure.

Dr Stephen Wright, GW's R&D Director, said, "This new regulatory filing seeks to build on our regulatory successes to date by expanding the approval of Sativex® to several additional European markets. We look forward to progressing this application during the first half of next year."

Sativex® oromucosal spray is a first in class endocannabinoid system modulator for the treatment of spasticity in MS. Sativex® has been developed by UK-based GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall, S.A. Sativex® is approved in the UK, Spain, Germany, Denmark, Czech Republic, Canada and New Zealand as a treatment of MS spasticity. The product is also in Phase III clinical development as a treatment for cancer pain.

Source: GW Pharmaceuticals plc (22/11/11)

Almirall, S.A. presented full results from three Phase III studies with Sativex®, in a satellite symposium at the 27th ECTRIMS congress,which took place in Amsterdam from 19th to 22nd October 2011.

These Phase III studies provide evidence of the long term efficacy of Sativex® (2.7 mg delta-9-tetrahydrocannabinol and 2.5 mg cannabidiol per puff) in symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

These data have led to the approval of this first-in-class medication in the UK, Spain, Denmark, Germany and Czech Republic, with additional countries expected to grant approvals in the near future. (1, 2, 3)

Professor H.P. Hartung, Chair of Neurology at Heinrich-Heine University, Dusseldorf, Germany and Chairman of the satellite symposium, commented: "Sativex® has proven to reduce the severity of symptoms and improve patients' quality of life and functional status, in patients with spasticity in multiple sclerosis, meaning that they can undertake everyday tasks more easily. Also, importantly, clinical experience to date has demonstrated that the tolerability profile of this medicine is favourable, with limited relevant adverse effects and - particularly reassuring - the drug does not appear to lead to withdrawal effects if patients suddenly stop using it."

"The Sativex® data show this is a unique opportunity to help patients with MS spasticity, a clearly underserved indication. We believe Sativex® will offer a new way to help the patients with MS spasticity", said Bertil Lindmark, Chief Scientific Officer at Almirall.

Professor Xavier Montalbán, Director of the Multiple Sclerosis Center of Catalunya and the Unit of Clinical Neuroimmunology, Vall d´Hebron University Hospital, Barcelona, also announced the award of 2 post-graduate clinical research grants by Almirall, aimed at fostering clinical research in multiple sclerosis spasticity across Europe. The project selection board is comprised of Professor Montalbán, who will provide guidance on the development of project proposals, Professor Hartung and Almirall's global Medical Affairs Department. The resulting projects will be developed in 2012, and results will be published by authors in Q2 2013.

Sativex® has been developed by the UK-based company GW Pharmaceuticals plc and is marketed in Europe (except the UK) by Almirall, S.A.

SOURCE: GW Pharmaceuticals plc (24/10/11)

People with multiple sclerosis in Galway and around the country could soon benefit from access to the world’s first prescription medicine derived from the cannabis plant.

Minister for Health Dr James Reilly - responding to a parliamentary question from local Fine Gael TD Sean Kyne - says his Department is examining how medications such as Sativex - the world’s first prescription medicine derived from the cannabis plant - can be legally prescribed and dispensed in Ireland.

This is an oral spray containing ingredients called ‘cannabinoids’ which are extracted from cannabis plants, grown under strict controls and in compliance with the law. It is primarily used in the treatment of MS and to combat cancer pain.

Deputy Kyne says the Minister is displaying “great foresight” and “progressive thinking” by examining the licencing of such medication.

“Both the UK and Canada have recently licensed Sativex following positive and encouraging results in clinical trials. I initially raised this issue with Minister Reilly after I’d been contacted by constituents with friends and relatives who suffer from MS. Some have been using cannabis for alleviating the pain associated with MS in fear and, it has to be noted, in contravention of the law as it currently stands.

“Clearly careful consideration must be given before any decision to licence medication derived from substances ordinarily associated with illicit drugs can be taken. I believe that the licensing of a medication such as Sativex would represent a major step forward as it has been medically proven to successfully alleviate some of the more debilitating symptoms of MS such as spasticity.

“It’s hoped that with the necessary legislative work, as well as consultation with stakeholders, Sativex would be available on prescription by the end of the year. Such availability would undoubtedly help people with MS in Galway and around the country.”

Source: Galway Advertiser © 2011 Galway Advertiser (22/09/11)

Summary: Open-label studies are not ideal for providing robust evidence for long-term maintenance of efficacy of medicines, especially where medicines provide symptom relief and where long-term use of a placebo may be problematic and not ethical.

Objective: To evaluate the maintenance of efficacy of Sativex in subjects who have gained long-term symptomatic relief of spasticity in multiple sclerosis (MS), and to assess the impact of sudden medicine withdrawal.

Methods: An enriched enrolment randomized withdrawal study design was used. Eligible subjects with ongoing benefit from Sativex for at least 12 weeks entered this 5-week placebo-controlled, parallel-group, randomized withdrawal study. Each subjects' previous effective and tolerated dose was continued.

Results A total of 18 subjects per group were enrolled. Demographics showed a mean duration of MS of 16.4 years, spasticity 12.7 years, mean duration of Sativex use of 3.6 years (median 3.4 years) and a mean daily dose of 8.25 sprays. Primary outcome of time to treatment failure was significantly in favour of Sativex (p = 0.013). Secondary endpoints showed significant changes in the Carer and Subject's Global Impression of Change scales in favour of Sativex.

Conclusions: Maintenance of Sativex efficacy in long-term symptomatic improvement of spasticity to a group of subjects with MS has been confirmed using this study design.

Summary:

Spasticity is a common and complex symptom, seen in about 60% patients with MS. It leads to reduction in mobility and makes transfers difficult, causes painful muscular spasms and also predisposes to the development of contractures. The management of spasticity needs to find a delicate balance between maximising the beneficial affects of treatment and minimising the negative effects. Various medications that are used include baclofen, tizanidine, dantrolene, benzodiazepines and anticonvulsants. Sativex is an extract of Cannabis sativa L and contains THC (delta-9-tetrahydrocannabinol) and cannabidiol (CBD) at a fixed ratio. Previous studies and meta-anlaysis on efficacy of Sativex, have reported a benefit of about 20% improvement from baseline in subject reported spasticity. In this study, the aim was to study the effect of the randomised withdrawal of Sativex in subjects who have been on this for a long time.

This was multicentre study done over five weeks. Subjects who had been diagnosed with MS and had used Sativex for relief of spasticity for at least 12 weeks were included. Subjects on any other anti-spasticity medication in addition, were required to be on a stable dose of the same for at least 3 months. Subjects who had any other condition that could cause spasticity were excluded. Any subject who had received botulinum toxin / rimonabant in the previous 3 months was also excluded. History of significant psychiatric, renal, hepatic, cardiovascular or convulsive disorder was also an exclusion criteria.

The primary endpoints were a cessation of randomised treatment before day 28 or a worsening of spasticity (20% increase on the mean spasticity NRS over last 7 days) or a clinically relevant increase in antispasticity medication requirements. Other secondary endpoints looked at included the subject goal impression of change, modified Ashworth scale etc.

The design of this study was the Enriched Enrolment Randomised withdrawal study design (EERW) – this is known to provide reliable evidence of long-term efficacy. After a informed consent and screening, eligible patients were asked to continue treatment with sativex at their current dose. A week later they were randomised into treatment groups – one continued with Sativex and the other was given a placebo. 37 patients were screened, one had a screen failure and thus 36 were randomised into 2 groups of 18 each. The two groups were well matched for age, mean EDSS, duration and type of MS. The most common adverse event was pain ( in 7 subjects receiving sativex). In association with lab values, the only adverse event was a non-serious increase in GGT. Six patients on the placebo failed treatment due to cessation of study medication. 8 on Sativex and 11 on placebo had worsening of spasticity. No subjects failed treatment due to a clinically relevant increase in antispastcity medication.

The primary efficacy endpoint (Time to treatment failure) was statistically significant in favour of Sativex. Also this small study showed no evidence of a withdrawal syndrome in subjects who stop Sativex suddenly despite a long period of medication with Sativex. Frequency and severity of adverse events was similar in both placebo and Sativex arms. While the number of subjects in this study was small, the lack of any new safety issues, strengthens data from previous studies. Until now most data for long term efficacy of Sativex is from long-term open label exposure and clinical observation. This study provides additional evidence on the maintenance of long-term efficacy of Sativex in patients who have been identified as responders.

Authors: Notcutt W, Langford R, Davies P, Ratcliffe S, Potts R.

Source: Mult Scler. 2011 Aug 30. (07/09/11)

Multiple sclerosis patients in London are being denied a pain-relieving drug by the NHS.

More than half a dozen trusts in the capital are advising doctors not to prescribe Sativex, according to the MS Society.

The drug can relieve spasms and muscle stiffness which, left untreated, lead to falls and fatigue.

It has been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) but health bosses are either refusing to fund the £11-a-day treatment or restricting its use, says the MS Society. Frustrated patients are being told to "wait and see" by health bosses.

They include Peter Frost, 57, who can no longer walk after being diagnosed with MS five years ago. His partner and full-time carer Betty Redpath have been trying to access Sativex since June last year.

Ms Redpath told the Standard: "Peter is a victim of a postcode lottery. He's getting worse and worse - he has no life and I hate seeing him in pain." MS Society spokesman Jayne Spink said the charity has been overwhelmed with calls from people refused Sativex." She added: "It seems to be a problem right across the capital."

South West London primary care trust said it was unable to comment on Mr Frost's case.

Source: Evening Standard © 2011 ES London Limited (23/08/11)

GW Pharmaceuticals plc today announces the launch in Denmark of Sativex® oromucosal spray as a treatment for the relief of spasticity in Multiple Sclerosis (MS).

Regulatory approval for Sativex® was granted in June 2011 by the health authorities in Denmark.

Sativex® was developed by UK-based GW Pharmaceuticals plc in specific response to the MS population's unmet need for a prescription cannabis-based medicine. Manufactured under Home Office licence at an undisclosed location in the UK it is marketed in Europe (except the UK) by Almirall.

Sativex® is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.

Sativex® is also approved and marketed in the UK, Spain and Germany. Launch in Sweden is expected before the end of 2011 with additional launches in Italy, Czech Republic and Austria expected in 2012.

Sativex® is also in Phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals plc (18/07/11)

GW Pharmaceuticals plc today announces the launch in Germany of Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as a treatment of spasticity due to Multiple Sclerosis (MS). This launch follows regulatory approval of Sativex®by the German health authorities in May. Germany has the highest prevalence of MS in Europe.

Sativex® is a first in class endocannabinoid system modulator and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). Sativex®offers the first new therapeutic option in decades to patients in Germany who have previously failed to respond adequately to other anti-spasticity medication. The spray is quickly absorbed through the oral mucosa, is easy to use for patients and enables them to optimally adjust their dosage. The medicine is already available for MS patients in the UK and Spain.

Spasticity (otherwise known as muscle stiffness) is a common symptom of MS affecting about 80% of the 130,000 MS patients in Germany. Spasticity has a negative impact on patients' daily lives, affecting their mobility, physical capabilities and thus their overall quality of life. Spasticity often leads to patients having to modify or give up certain activities and to the need for help from a family member or carer. If not treated adequately, spasticity can have long term effects and complicate treatment of other symptoms.

"Spasticity in multiple sclerosis can have a significant negative impact on patients' daily lives. In particular, muscle cramps and stiffness are usually very painful and can disturb sleep. This new medication is therefore a highly promising treatment option for both neurologists and patients", said Prof. Dr. med. Juergen Koehler, Managing Director and Medical Head of the MS Treatment Center, Kempfenhausen.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in MS, while alleviating associated symptoms. The relief of symptoms and positive impact on sleep quality and mobility enables patients to better cope with everyday tasks.

"Almirall's philosophy is to provide innovative solutions for patients. This first new medication for treating spasticity in multiple sclerosis offers an important new treatment option to help multiple sclerosis patients improve their spasticity and associated symptoms", said Farid Taha, Managing Director, Almirall, Germany, Austria and Switzerland.

Sativex® contains active ingredients called 'cannabinoids', which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains. A receptor is a site on a brain cell where certain substances can stick or "bind" for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a 'dimming down' of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.

In addition to Germany, Almirall also expects to launch Sativex® in Denmark and Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.

Sativex® is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Sativex® was developed by GW Pharmaceuticals. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals plc (04/07/11)

Susan Costello was diagnosed with a progressive form of the neurological disease multiple sclerosis in 2003, soon after getting married.

Her condition has slowly deteriorated.

‘I can’t feel anything in my right foot – it’s like a piece of dead meat,’ says the 49-year-old mother of one from Prestwich, Manchester.

‘When I walk, I often need to lean against a wall or ask for a friend to help support me.

Every day I get painful spasms in my right leg, which make it stiffen and stop me sleeping.’

But there is a drug that can help MS sufferers like Susan.

Sativex is the first cannabis-derived medicine to be licensed in the UK. It is applied under the tongue by an oral spray and absorbed into the bloodstream.

The drug works by stimulating the cannabis receptors in the brain and nervous system, dampening overactive nerve cells and relieving spasticity by targeting the area of the brain that controls muscle tension.

Sativex does contain THC, the chemical that gives recreational users of cannabis a ‘high’.

But patients using Sativex don’t get high because the dose is much lower and it is a controlled form of the substance.

Sativex comes with more than ten years of clinical trials proving its effectiveness in treating the symptoms of MS and is proven to help reduce pain and spasticity, improve sleep and causes few side effects.

Indeed, Susan was on one of the trials for Sativex and found it incredibly effective.

But, despite numerous requests from her neurologist saying she needs it and is eligible for it, her local Primary Care Trust, NHS Salford, refuses to prescribe her the drug.

Susan, an HR manager for a tram company, is far from alone.

Almost a year after Sativex was licensed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the majority of those with MS in the UK who need it remain unable to obtain it.

MS affects about 100,000 men and women and children in the UK.

It is a neurological condition that damages the nerves and affects the transfer of messages from the central nervous system to the rest of the body.

It affects everybody differently but common symptoms include blurred or double vision, numbness, limb weakness, spasticity and pain.

At later stages there can be loss of co-ordination and speech impairment.

The MS Society says it has been contacted by hundreds of sufferers unable to access Sativex despite their doctors’ requests, and thousands more have made enquiries about how to get it.

Many PCTs are issuing blanket refusals to all patients on grounds of ‘cost effectiveness’ and ‘no proof of efficacy’.

'It doesn't seem fair': Susan Costello can't understand how drug users are prescribed methadone on the NHS but she is refused a cannabis spray which would ease her agony.

Susan says that when she took Sativex, her symptoms improved immediately.

‘An hour after the first spray I had sensation back in my right foot for the first time in years,’ she recalls.

‘It helped my balance, stopped the spasms and allowed me to move around much more easily.

I could co-ordinate my limbs again. My fatigue wasn’t so bad either.’

For 18 months after the trial ended, Susan paid for private prescriptions of Sativex, until she was no longer able to afford it.

When the drug was licensed last year – for people who, like Susan, do not respond adequately to other anti-spasticity medication and who demonstrate a clinically significant improvement in an initial trial of the therapy – she assumed she would automatically receive it on the NHS.

But her application was declined.

A spokesman for NHS Salford said: ‘We follow guidance produced by the Greater Manchester Medicines Management Group, in July 2010, regarding Sativex.'

The guidance is as follows: “The group does not recommend the use of Sativex for the treatment of moderate to severe spasticity due to multiple sclerosis (MS) who have not responded to other anti-spasticity medication and who demonstrate a clinical improvement during a trial of therapy."

Although Sativex showed some benefits against placebo, as the data is not yet fully published the clinical significance of this is unclear.

The main trial was 12 weeks; so longer-term safety data for Sativex are currently unknown.

Sativex was deemed to be a low priority for funding.

Since she has been unable to get Sativex, Susan has been taking a drug called Baclofen for her spasticity.

Not only is it less effective but it has unwelcome and unpleasant side effects, such as making her unable to control her bladder or bowels. Sativex had no side effects for her.

Dr William Notcutt of the James Paget Hospital at Great Yarmouth says: ‘Imagine having continuous, severe cramps and pain and not being able to sleep.

Knowing that there’s something that can help, but you can’t get it, seems very unjust.

‘Sativex is actually no more expensive than other drugs I prescribe for MS and rheumatoid arthritis.’

Susan says: ‘It doesn’t seem fair that I can’t get a drug I need and that works. Drug abusers are prescribed methadone on the NHS. Their condition is self-inflicted. Mine isn’t.’

Source: The Daily Mail © Associated Newspapers Ltd 2011 (20/06/11)

Almirall, S.A. and GW Pharmaceuticals plc announced that the health authorities in Denmark have granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medication.

Regulatory approval for Sativex® has been granted after the recent change in the local laws. Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS, currently available in the UK and Spain.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activities. ii

Approval in Denmark follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all countries involved recommending approval. Approval for Sativex® was granted in Germany on 26th May 2011 and the product is expected to be launched there in July. In addition to Germany and Denmark, launch is also expected in Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.

A further MRP is planned for later 2011 involving other European countries, in order to make this medicine available to more patients suffering from MS.

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals plc (08/06/11)

Former Army chaplain Peter Bayley is taking legal action against the NHS after he was refused the medication he needs to ease his severe Multiple Sclerosis symptoms.

NHS North Staffordshire has told Mr Bayley it will not fund his treatment with licensed MS drug Sativex, because his circumstances are not "exceptional" enough.

But the 72-year-old former Methodist minister is virtually housebound and is now only able to use his brain, right arm and right eye.

He had been importing the drug from Canada for six years for £1,252 a year.

However, after the drug was approved in Britain last year, the cost of Mr Bayley's private prescription has risen to £525 a month because the original manufacturer was taken over.

Mr Bayley – whose story was first featured in The Sentinel in April – says the Sativex spray eases the symptoms of his MS, by alleviating pain, reducing the rigidity in his limbs and controlling depression brought on by the condition.

But, due to the increased costs, he will soon be unable to afford the drug.

He said: "There is a solicitor who wants to take up my case. Now I need to get all my documentation together.

"It came about as a result of the article in The Sentinel. The daughter of an old friend is a solicitor working in Manchester. She saw it, thought it was appalling and took it into work with her. One of her colleagues likes to take on cases like this and is coming to see me.

"Since the article, I've had calls from people living in Alton and Bradwell who claim they are getting Sativex on prescription from their GP, so why they should have it and I can't, I don't know.

"I can't carry on paying £525 a month for it. But the very people I would expect to help me – the health service – I'm having to fight."

Mr Bayley – who served in the Army from 1957 until 1986, as a regular trooper, an elite soldier with the paratroop regiment and a chaplain – has had MS for 23 years.

His condition has got steadily worse, without any remission. MS causes signals from the brain to the nerve endings to get lost, which means sufferers can lose control of their body.

Mr Bayley went from a super-fit soldier – ranked Lieutenant Colonel when he left the Army in 1986 – to being almost paralysed. He is blind in one eye and wheelchair-bound.

His wife Valerie is his full-time carer.

Mr Bayley, of Newcastle, added: "There's no doubts about the benefits of Sativex. It helps the stiffness in my limbs – and my mood."

Figures revealed in The Sentinel on Saturday showed that patients in Stoke-on-Trent were 10 times more likely to win their NHS funding battle than those in the rest of North Staffordshire.

Ian Syme, co-ordinator of North Staffordshire Healthwatch, said: "This is another example of people having to climb mountains to access a service.

"It is a situation where policy at the PCT is not taking into consideration the patient's clinical need."

Sativex was licensed in June as a prescription-only medicine on the NHS for MS treatment for use in the UK.

But NHS North Staffordshire does not routinely commission Sativex because it is still a new drug. The PCT says Mr Bayley was denied treatment because not enough information had been provided to show "exceptionality".

A spokesman said: "Providing health care to the communities we serve is our priority. Each request is fully reviewed following a board-approved policy.

"We are committed to providing the best service we can to the whole of North Staffordshire using our resources wisely. We do not have the resources to fund every service, treatment or procedure which every individual may want.

"Where treatment is not routinely funded, cases are considered on an exceptional basis through our individual funding request process.

"We are always willing to consider further evidence of exceptionality."

Source: thisisstaffordshire.co.uk © Northcliffe Media Ltd 2011 (31/05/11)

The NHS has been criticised by doctors for denying multiple sclerosis patients access to a drug derived from cannabis which regulators have approved to help relieve their symptoms.

MS specialists claim primary care trusts (PCTs) in England are exacerbating patients' pain and suffering by refusing to let them use Sativex. Some PCTs say the drug, which costs £11 a day, is not worth the money, but doctors insist it is the only medication that can help some patients.

Sativex can relieve spasticity, or muscle stiffness, in MS patients. It became the first cannabis-based medicine to be licensed for use in the UK almost a year ago by the Medicines and Healthcare products Regulatory Agency (MHRA).

Only doctors specialising in MS, such as neurologists and pain consultants, are allowed to prescribe the drug, which is an oral spray. It can only be prescribed to those who found that other drugs did not bring relief, or who experienced bad side-effects while taking them.

Patients in the West Midlands, Yorkshire, East Midlands, Suffolk and south-west England are unable to obtain Sativex. Patients in Scotland have also had difficulty getting it.

Dr Steve Sturman, a consultant neurologist and clinical director of neurology at City hospital in Birmingham, is unable to prescribe Sativex to patients because of the stance taken by NHS decision-makers in the West Midlands. "As a consultant it is disheartening when I cannot prescribe a licensed treatment to my patients, despite careful assessment of the evidence," he said. "I have a number of patients who may benefit from Sativex, but with this local decision in place it looks like they are going to go without."

Susan Garrity, who was diagnosed with MS in 2000, has been refused Sativex despite her neurologist arguing that it would benefit her. The 69-year-old from Alfreton, Derbyshire, said: "I've tried every other treatment going for spasticity and nothing works. I was excited when I saw Sativex had been licensed; it gave me another treatment option, but I've been refused and I'm not sure why," she said.

"I see my granddaughter playing in the garden and she shouts at me to chase her, but I can't. It breaks my heart. I'm upset and frustrated."

Sativex can make it easier for MS patients to move. It can ease spasticity, which if left untreated can lead to pressure sores, falls and serious fatigue.

Dr Neale Pimenta, a GP who runs an MS clinic at Darent Valley hospital in Dartford, Kent, said Dartford and Gravesham PCT were funding Sativex for 25 patients who are already on it. But it has refused to let about 25 others have MS, despite pleas from their hospital's specialist.

"You could say that it's heartless. The trouble is, the people making these decisions don't understand the disease," said Pimenta, who was diagnosed with MS himself in 2002. "The PCT's attitude is causing unnecessary suffering. Sativex isn't a magic cure for MS; that has to be stressed. But this medication will significantly reduce people's symptoms - as well as bladder problems, sleep disturbance and tremor - yet they can't get it. The NHS should be prescribing this, not restricting it unfairly." Dr Pimenta said it was "financially short-sighted" to deny his patients Sativex as this forces MS sufferers with mobility problems to travel to London to get the drug at three hospitals that do prescribe it: Charing Cross, St Mary's and the National Hospital for Nervous Diseases.

The Peninsula Health Technology Commissioning Group, which decides what treatments the NHS will pay for in Devon and Cornwall, decided it would not fund the drug. The group accepted data showing Sativex boosted patients' quality of life, but pointed out that it came from a clinical trial lasting just four months, when the drug is intended for long-term use. "So there is uncertainty over benefit in the long-term," the group concluded. That, as well as the drug's high cost "makes the improvements in quality of life produced by this treatment poor value for money to the NHS".

The MS Society claims Garrity's case is "the latest example of inconsistent and dubious decision-making by local health authorities on Sativex". Denying the drug ultimately costs the NHS more because patients with unrelieved spasticity symptoms end up needing hospital treatment, the charity added.

Dr Jayne Spink, the society's director of policy and research, said the drug had been shown to be safe and effective after undergoing extensive clinical tests. "We've been overwhelmed with inquiries from people with MS who've been upset and frustrated that they can't access the treatment. We'd like to see Sativex available to anyone who might benefit from taking it."

Almost 3,500 people have downloaded guidance from the society's website about trying to access Sativex, including more than 700 in March and April.

PCTs are having to make individual decisions about Sativex because the National Institute for Health and Clinical Excellence (NICE) has not yet ruled if it represents good value for money for the NHS, said the Department of Health. A spokeswoman said: "In the absence of NICE guidance, primary care trusts make local funding decisions on individual treatments taking into consideration all available evidence.

"NICE is currently developing guidance on Sativex as an add-on treatment of moderate to severe spasticity in multiple sclerosis. Final guidance is expected to be published in 2012."

The government's NHS plans will see family doctors replace PCTs as the decision-makers on which treatments patients receive, she added. "Our proposals to modernise the NHS would empower GPs to make these funding decisions based on clinical knowledge and an understanding of their patients' individual needs."

Source: guardian.co.uk © Guardian News and Media Limited 2011 (31/05/11)

Almirall, S.A. and GW Pharmaceuticals plc today announce that the health authorities in Germany have granted regulatory approval for Sativex®(Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to Multiple Sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication(i). Sativex® is expected to be launched in Germany in July 2011.

Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). The medicine is already available for MS patients in the UK and Spain.

Spasticity (otherwise known as muscle stiffness) has a negative impact on patients' daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleep. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder and sleep disturbance.

Approval in Germany follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all six countries involved recommending approval. These countries were Germany, Denmark, Sweden, Italy, Czech Republic and Austria. In addition to Germany, launch is also expected before the end of 2011 in Denmark and Sweden. Launches in Italy, Czech Republic and Austria are expected in 2012.

A further MRP submission is expected to be made later in 2011 with a view to expanding the approval of Sativex® to additional European countries.

Justin Gover, Managing Director of GW, said, "Having recently successfully launched Sativex® in Spain, we are very pleased to have now received regulatory approval in Germany. Germany has the largest MS population in Europe and we look forward to offering people with MS in Germany the opportunity to benefit from Sativex® as a new first in class treatment to treat their spasticity."

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals plc (26/05/11)

Patients with Multiple sclerosis (MS), an inflammatory disease that affects the nervous system, might not be prescribed the drug Sativex as distribution has been halted in Scotland due to budget cuts and the awaited approval by the Scottish Medicines Consortium (SMC).

The cannabis-based drug is orally administered by spraying it under the tongue of the patient and promises pain relief where other types of medications have failed.

However, Sativex is an expensive drug to produce and following cuts to the NHS some local authorities south of the border have deemed it as not being cost-effective, leaving many MS patients short of alternative treatments.

The use of Sativex has been controversial, despite having been deemed safe by medical authorities in July 2010. Control over the production and transportation of the drug is strict, and the medical marijuana plants used to produce it are grown at secret locations in the South of England.

The MS Society released a statement to The Journal outlining the difficulty in obtaining the drug for MS sufferers in Scotland: “Usually a clinician will only prescribe a licensed treatment if it has been approved for use by the SMC and accepted by the local health board.”

Asked about the benefits of the drug the MS Society stated: “Just under 50 per cent of people with MS who have not responded to other treatments can be expected to show a clinically significant response to Sativex after four weeks treatment.”

The Society further described the delay of the distribution of Sativex in Scotland as “disappointing” and said that: “The MS Society believes that people with MS should have access to proven treatments for their condition no matter where they live in the UK.”

Sativex is on the market in the UK, Spain, Canada and New Zealand through Swiss pharmaceutical giant Novartis. It is currently awaiting regulatory approval in Germany, Italy, Sweden, Denmark, Austria and the Czech Republic.

Source: The Edinburgh Journal © The Edinburgh Journal Limited. 2011 (04/05/11)

GW Pharmaceuticals plc today announces that Sativex® oromucosal spray has been approved in the Czech Republic as a treatment for spasticity due to Multiple Sclerosis (MS).
 
This approval follows GW's announcement on 22nd March 2011 that the European Mutual Recognition Procedure had successfully completed with all six countries involved recommending approval. The countries involved in the MRP were Germany, Italy, Denmark, Sweden, Austria and the Czech Republic. The Czech Republic is the first of these countries to approve Sativex. The remaining countries involved in the MRP are expected to approve Sativex in the coming months.
 
Launch timing in each country will be dependent on national regulations concerning pricing and reimbursement. In accordance with previous guidance, GW's marketing partner, Almirall S.A., anticipates launch in Germany, Denmark and Sweden before the end of 2011 with the remaining countries, including the Czech Republic, expected in 2012.
 
Sativex® is also in phase III clinical development for the treatment of cancer pain, Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals (15/04/11)

U.K. drug maker GW Pharmaceuticals PLC said it has signed a license deal with Novartis AG to commercialize its cannabis-based multiple sclerosis treatment Sativex in a range of markets including Australia, parts of Asia and Africa.

Under the agreement, GW will get an upfront payment of $5 million and receive a further $28.75 million dependent on certain approvals and commercial milestones.

Novartis will have exclusive rights to sell Sativex in Australia; New Zealand; Asia, excluding Japan and China; the Middle East, excluding Israel; and Africa. Regulatory filings for the treatment will be submitted in some of these regions during 2011, GW said.

"We would hope that the first launches in this region would start to occur during the second half of 2012 or early 2013," Managing Director Justin Gover told Dow Jones Newswires.

Sativex, a treatment for spasticity in multiple sclerosis patients, has already achieved regulatory approval in a number of European markets, where the firm's partner Almirall SA (ALM.MC) is selling the drug.

Gover said there was a clear "regulatory rationale" for the deal, which covers markets where it should be relatively easy to secure approvals. "A large number of these markets shouldn't require additional development work beyond that which is required in Europe. Novartis in essence is licensing a developed product in this region," he said.

Sativex is also in Phase III clinical trials in the U.S., where it is licensed to Otsuka Corp, for the treatment of cancer pain.

Novartis also has rights to market Sativex for cancer pain in the regions covered by the deal.

The Swiss pharmaceutical giant saw off competition from a number of global and regional drug companies to win the license for Sativex, Gover said.

Source: The Wall Street Journal Copyright ©2011 Dow Jones & Company (11/04/11)

The National Institute for Health and Clinical Excellence (NICE) has been commissioned to carry out a Technology Appraisal of Sativex (nabiximols) as an add-on treatment for moderate to severe spasticity in multiple sclerosis.

However, following the recent draft scope consultation and further discussions with the Department of Health, it was recognised that there is a potential for overlap between the Technology Appraisal for Sativex and the proposed review of Clinical Guideline No. 8 ‘Management of multiple sclerosis in primary and secondary care’. Therefore it has been decided that the Technology Appraisal of Sativex will be suspended until the outcome of the review decision process for the Clinical Guideline is known. A decision on the review of the Guideline is due in June 2011.

The Clinical Guideline covers the full range of care that should be available to all adults with MS on the NHS, including how a diagnosis of MS should be made and given. There is also information on the range of treatments that should be offered.

"This decision by NICE to consider Sativex as part its review of the Clinical Guideline No 8 'Management of multiple sclerosis in primary and secondary care' demonstrates common sense and reflects exactly what the MS Trust suggested in our submission to NICE. Sativex is only to be used in a small cohort of people with MS who do not benefit from other conventional medication for treatment of their spasticity. It would be foolish and wasteful to commit resources to a complete NICE review of Sativex. Of more relevance currently is the NHS allocating funding for those people who are deemed, after specialist assessment, to be in clinical need of Sativex." Nicola Russell, Director of Services, MS Trust.

Source: MS Trust © 2004-2011 Multiple Sclerosis Trust (05/04/11)

GW Pharmaceuticals Plc's pioneering cannabis drug Sativex has been recommended for approval in the six other European countries targeted by the British company and Spanish partner Almirall.

National approvals are now expected in Austria, Czech Republic, Denmark, Germany, Italy and Sweden from mid-2011 onwards, with launches in Denmark, Germany and Sweden likely before the end of 2011, GW said on Tuesday.

The medicine was expected to go on sale in the remaining countries in 2012.

GW shares were up 2.5 percent in early trade.

Sativex -- sprayed under the tongue as a treatment for spasticity in multiple sclerosis -- is already approved and marketed in Britain and Spain. The latest green lights for the drug come under the European mutual recognition procedure.

"Today's news represents a major step forward for the international commercialisation of Sativex," GW's research director Stephen Wright said.

Sativex is sold as a prescription drug in Britain by Bayer at a cost of around 11 pounds ($18) per day, while Almirall is the marketing partner elsewhere in Europe.

Sativex became the world's first cannabis medicine to win regulatory clearance when it was approved in Canada in 2005 for neuropathic pain. Its roll-out in Europe for MS opened up a bigger market.

GW -- also hoping to get Sativex approved as a treatment for cancer pain -- extracts the active ingredients in Sativex from marijuana plants grown at a secret location in the English countryside.

Source: Reuters © Copyright 2011 Thomson Reuters (22/03/11)

Evidence from clinical trials shows that Sativex® has a positive impact on spasticity, sleep quality and mobility and enables patients to carry out everyday tasks such as getting up, getting dressed or washed. This affords patients greater independence and reduces the frequency of spasms. It is estimated that in Spain there are around 40,000 people with MS  and up to 75% of them suffer from spasticity in the course of their disease.

Doctor Rafael Arroyo, head of the Multiple Sclerosis unit of the Department of Neurology in Hospital Clinico San Carlos in Madrid said, “This is encouraging for patients and really interesting news for healthcare professionals, because it provides another treatment option for our MS patients who up to now had not been able to obtain an improvement of symptoms such as spasticity, muscle spasms, cramps or stiffness”.

Spasticity (otherwise known as muscle stiffness) has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleep. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments.

Two websites and a 24h patient medical care phone service

Almirall has set up a specific website on symptoms related to MS - http://www.vivirconem.com. - for patients and family members or carers, which contains a variety of audiovisual content aimed at providing a clear understanding of the specific symptoms of the disease and useful tips for daily life. There is also a second website -http://www.tupuntodeapoyo.com - and a 24h telephone medical care service to help patients follow their treatment guidelines (dose titration of Sativex® in order to find the optimal number of daily doses). This website has restricted access for patients to whom Sativex® has already been prescribed.

"In line with our philosophy of providing innovative solutions to patients, we are introducing in Spain the novel medicine Sativex®, the first drug offering those affected by Multiple Sclerosis a proven alternative to help them improve their spasticity and associated symptoms. This launch is complemented with on-line initiatives to support and inform them about its use, reinforcing our commitment to wellness and health", said Luciano Conde, Chief Operating Executive of Almirall. "We also expect to launch Sativex® in other European countries later in 2011", he said.

According to the official communication from the Spanish Ministry of Health, Sativex® is financed by the National Health System with 100% reimbursement and the product is required to be dispensed from hospital pharmacies for outpatients.

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Source: GW Pharmaceuticals plc (14/03/11)

Results from a phase III clinical study published online yesterday in the European Journal of Neurology Early View showed that about half of all people with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to standard anti-spasticity therapy, find that adding Sativex® Oromucosal Spray (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)), to their existing medication can improve the debilitating symptoms of spasticity associated with MS.¹

The primary efficacy endpoint was the change in a validated, 10 point (0-10) self-reported spasticity numerical rating scale (NRS) from the point of randomisation to the end of the treatment.1  Sativex® was shown to provide significant improvement, compared to placebo, in the NRS spasticity score,  spasm frequency and sleep disturbance related to spasticity.¹

After a four-week, single-blind therapeutic trial period in 572 patients, Sativex® reduced the mean NRS score for spasticity by 3.01 points, from a baseline of 6.91 points.¹ 48% of patients achieved a clinically meaningful improvement of ≥20%  in  spasticity severity during this initial period.¹    Of these responders, 241 proceeded into a 12-week, randomised, placebo-controlled trial phase.¹ At the end of the trial, Sativex® had reduced the mean spasticity 0-10 NRS score in responders by significantly more than placebo (estimated treatment difference 0.84 points; p=0.0002).¹ The number of patients achieving an improvement in spasticity NRS of ≥30% by the end of the trial was significantly greater in the Sativex® group than the placebo group (74% vs. 51%; p=0.0003).¹

Professor John Zajicek, Honorary Consultant in Neurology, Derriford Hospital and Chair of Clinical Neurosciences at PCMD, University of Plymouth said, ‘We have been aware for a long time that cannabinoid medicines can significantly improve spasticity, which is a common, complex symptom of MS, and now the results from this study prove the positive impact they can have on patients’ symptoms, and ultimately their lives.’

About the study¹
A 19-week follow-up, multicentre, double-blind, randomised, placebo-controlled, parallel-group study in subjects with MS spasticity not fully relieved with current anti-spasticity therapy. Subjects were treated with Sativex®, as add-on therapy, in a single-blind manner for 4 weeks, after which those achieving an improvement in spasticity of ≥20% progressed to a 12 week randomised, placebo-controlled phase.

Source: GW Pharmaceuticals plc (02/03/11)

GW Pharmaceuticals' pioneering cannabis drug is getting a mixed reception four months into its launch across Britain, its first European market.

A survey of primary care trusts today found several that were not recommending Savitex to multiple sclerosis patients, with many viewing it as “low priority”.

But GW managing director Justin Gover said the group's strategy was never based on blanket acceptance by PCTs. He added that all new medicines faced challenges and that any suggestion Sativex was suffering unique difficulties was misplaced.

“GW is very pleased with the Sativex launch and has received very encouraging clinician feedback and support,” he said.

Sativex, which is sprayed under the tongue, is sold as a prescription drug in Britain by GW's partner, German group Bayer, at a cost of around £11 per day.

Its approval last June was a major success for GW, which grows cannabis plants at a secret location in the English countryside and has spent 11 years developing the product.

But GW must win acceptance among patients and doctors as it prepares to take the drug into other markets. Sativex, also available in Canada, was approved in New Zealand this week and is expected to go on sale in Spain before the end of this year.

PCTs can make decisions on use of the drug as it has not been assessed for cost-effectiveness by the National Institute for Health and Clinical Excellence.

Source: London Evening Standard © 2010 ES London Limited (08/11/10)

Cannabis based medicines group GW Pharmaceuticals has had its Sativex treatment for the relief of spasticity in Multiple Sclerosis (MS) approved by the New Zealand regulatory authority.

The mouth spray, which contains two cannabinoids or active ingredients - THC and CBD - is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant.

It’s the fourth approval for Sativex in recent months following positive decisions in the UK, Spain and Canada.

“We are delighted that Sativex has received positive endorsement from another of the world's most highly regarded regulatory authorities," GW R&D director Stephen Wright said.

Source: ShareCast © Digital Look Ltd 1998-2010 (03/11/10)

Almirall, S.A. announced that results from three pivotal clinical studies of Sativex® were presented in a Satellite Symposium at Europe's leading multiple sclerosis conference, the 26th annual congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which is taking place in Gothenburg, Sweden from 13-16 October.

These Phase III studies, the main results of which were first announced some months ago, provide robust evidence of the long term efficacy of Sativex® (27 mg delta-9-tetrahydrocannabinol and 25 mg cannabidiol) in symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. These data have in recent months led to the approval of this first-in-class medication in the UK, Canada and Spain (this last country pending pricing and reimbursement conditions).1,2,3

Sativex® is administered as a mouth spray. Individual patients have the flexibility to adjust their dosage in the way which best suits their own level of spasticity and also the daily variations in their symptoms.

Professor Patrick Vermersch, Head of Neurology, University Hospital of Lille, France said, “Sativex® has produced highly promising results in the treatment of spasticity due to multiple sclerosis. Sativex® has shown it reduces the severity of symptoms as well as improving patients’ quality of life and functional status, meaning that they can complete everyday tasks more easily. As the first new treatment for patients with this condition in ten years, Sativex® is a welcome option for a disease area in which there is a clear unmet need.”

In clinical trials, the proportion of multiple sclerosis spasticity patients achieving a ≥30% improvement in their symptoms was significantly higher with Sativex® than with placebo.1,2,3 Sativex® also demonstrated improvements in spasticity associated symptoms, including spasms, sleep disruption and everyday functionality.2,3 During these studies, Sativex® was not associated with the adverse events which typically occur with recreational cannabis use, demonstrating very low potential for causing psycho activity or intoxication. The most frequent adverse events were transient dizziness or somnolence, usually of mild to moderate severity.

Sativex® obtained regulatory approval in Spain in July 2010 and is now undergoing pricing and reimbursement approval from the Spanish Ministry of Health which is expected to be completed during the 4th Quarter of 2010. It is currently marketed in the UK and Canada.

Sativex® has been developed by the UK-based company GW Pharmaceuticals plc and will be marketed in Europe (except the UK) by Almirall, S.A.

Source: G.W. Pharmaceuticals (14/10/10)

GW Pharmaceuticals plc announced that results of a Phase II clinical study of Sativex® (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)) in the treatment of bladder dysfunction in people with Multiple Sclerosis (MS) have been published in the peer-reviewed Journal, Multiple Sclerosis.

The authors of the paper state that “this study does provide clinical evidence across a range of bladder-related endpoints that Sativex® has some beneficial effect when used for treatment of the bladder symptoms in patients with MS”.

Preliminary headline results from this study have previously been announced by GW. The paper is published online and will appear in the print copy of the Journal in the coming monthsi.

The study was a double-blind, randomized, placebo-controlled, parallel-group trial of Sativex® in 135 people with MS and overactive bladder (OAB) that was not responding adequately to currently available treatment (e.g. oxybutinin). During the study, patients remained on their existing bladder medication. Treatment duration in the study was 8 weeks.

In the trial, Sativex achieved statistically significant improvements in a range of bladder symptoms, including nocturia (p=0.01), daytime frequency (p=0.044), frequency per 24 hours (p=0.001), and bladder symptom severity (p=0.001). A significant effect was also seen in the patient’s global impression of change (p=0.005). There was also a strong trend in favour of Sativex in urgency (p=0.07).

There was no significant effect on incontinence, the pre-specified primary endpoint of the study. The paper’s authors state a possible reason for this may be the relatively low baseline number of incontinence episodes resulting from patients remaining on their existing medication.

In the trial, the adverse event data showed the medicine to be generally well tolerated.

Professor Cris Constantinescu, Professor of Neurology, University of Nottingham, said, “Bladder dysfunction is a common feature of MS and many current treatments are less than ideal due to lack of efficacy or tolerability. These data provide promising evidence for the positive effects of Sativex® on bladder symptoms in patients with MS.”

Dr Stephen Wright, GW’s R&D Director, said: “This study demonstrates that in people with MS who have exhausted other treatments, Sativex® improved some of their most troublesome symptoms of bladder dysfunction. We believe that Sativex® has broad therapeutic potential and this area represents one of a number of options for future development of this important medicine.”

In recent months, Sativex® has been approved in the UK, Spain and Canada as a treatment for spasticity in MS. Sativex is not licensed as a treatment for overactive bladder.

Sativex® is marketed in the UK and Canada by Bayer Schering Pharma and will be marketed in the rest of Europe by Almirall S.A.

Source: GW Pharmaceuticals plc (22/09/10)

A woman with multiple sclerosis (MS) has criticised a decision which means she has to pay £445 a month for a drug to ease her condition.

Sheila Clarke, from Whitby, uses the cannabis-based drug Sativex, which has been licenced for NHS use.

It is available in some parts of the country but health trusts in Yorkshire do not fund it because of concerns over its cost effectiveness.

Ms Clarke said: "One day my savings will run out and I'll go back to pain."

Sativex was licenced by the Medicines and Healthcare Products Regulatory Agency in June and is available from some health trusts.

However, a panel of regional experts in MS have said there is no compelling evidence of benefits to patients from the drug and decided primary care trusts in Yorkshire cannot prescribe it.

Ms Clarke's doctor Rory Newman said: "Before she tried it she had been having a great deal of pain, a lot of problems particularly with spasms around her neck and shoulder and it became clear quite quickly that the Sativex was helping a lot with this... she was much more comfortable and her quality of life improved."

Ms Clarke said she was upset that she was unable to get the drug from her health trust NHS North Yorkshire and York.

"They say the benefits are not outweighed by the cost. How do they know this, they don't have MS, they don't have the symptoms so they couldn't know it."

Scarborough and Whitby MP Robert Goodwill said: "In other parts of the country it is being prescribed and I think we need to make sure that people who pay the same taxes wherever they live in the country get a similar service from the NHS."

In a statement, NHS North Yorkshire and York said it did not "routinely fund the prescribing of Sativex for patients with multiple sclerosis symptoms including spasticity and pain".

It continued: "This is the agreed regional policy across 14 PCTs within Yorkshire and the Humber and has been in place since March 2004.

"The panel concluded that Sativex lacked compelling evidence of benefit for the target population and was unlikely to be cost effective for use within the NHS."

Source: BBC News © British Broadcasting Corporation 2010 (15/09/10)

GW Pharmaceuticals plc and Bayer Inc., a subsidiary of Bayer AG, today announced that Health Canada has approved Sativex® [delta-9-tetrahydrocannabinol 27 mg/mL (from Tetrabinex® - cannabis sativa L. extract) and cannabidiol 25 mg/mL (from Nabidiolex® - cannabis sativa L. extract)] as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS).

Sativex® is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol and cannabidiol. This means that people in Canada with MS experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps, will now have a new treatment option in addition to standard therapy.

The MS spasticity indication has received a full marketing authorization, or Notice of Compliance (NOC), from Health Canada. Sativex® is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with MS who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy. 

In addition to this new NOC, Health Canada approved Sativex® in 2005 under its Notice of Compliance with Conditions (NOC/c) policy as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis, and granted a further NOC/c approval in 2007 as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.1

“Health Canada’s approval of a third indication for Sativex® demonstrates the broad applications of this medicine,” said Dr. Shurjeel Choudhri, Chief Medical Officer and Head, Medical and Scientific Affairs, Bayer Inc. “Sativex® meets a significant unmet medical need by improving the symptoms of spasticity in patients with MS who have failed to respond to current anti-spasticity medication. We believe that this approval represents an important step forward in the available treatment options for the MS patient population in Canada.”

Dr Stephen Wright, R&D Director, GW, said: “Following recent approvals in the UK and Spain, Canada is now the third major country to approve Sativex® for symptomatic relief of spasticity in adult patients with MS. This regulatory approval has come several months earlier than anticipated and GW looks forward to working with Bayer to develop the marketing strategy for this new indication. We are delighted that the international regulatory program for Sativex® is continuing its positive momentum.”

Source: GW Pharmaceuticals plc (31/08/10)

A Cannabis-based drug that may relieve symptoms of multiple sclerosis will be denied to Calderdale patients.

NHS Calderdale has confirmed the oral spray Sativex will not be routinely funded for the area's estimated 300 sufferers.

The newly-licensed medicine contains cannabinoids, extracted from cannabis plants, which can help to relieve painful muscle spasms.

There are fears that blocking its use could criminalise patients, who may resort to taking the class B drug instead.

MS sufferer Richard Schofield, from Halifax, said: "Some people say smoking it or having it in a cake does alleviate their problems and I'm quite sure there would be people who would go ahead with it."

Mr Schofield, who said he is satisfied with the medication he is prescribed, added: "For me personally, I don't think Sativex would be of any benefit at the moment, but I'm sure for some people it may well be an answer."

Mr Schofield's wife Liz, a support officer at the Halifax branch of the MS Society, said: "Living with MS is difficult and the symptoms can be very debilitating - anything that helps people manage their condition is good news and it should be made available if there is a clinical need."

The spray has been approved by the Department of Health and was licensed for the first time in the UK in June by the Medicines and Healthcare products Regulatory Agency.

The medicine costs £125 for a 10ml vial - around £11 per patient each day - and the decision to fund it will be down to individual primary care trusts.

NHS Calderdale said it had rejected the drug on advice from the Yorkshire and the Humber Specialised Commissioning Group.

A spokesman for the group said: "We agreed that Sativex does not provide enough benefit to patients to justify its high cost. We also thought that this medicine had not been tested over a long enough time to be able to tell if it will work safely in people with multiple sclerosis, who often need treatment for many months or years."

Laura Weir, head of policy and campaigns at the MS Society, said: "It is extremely unfortunate that Yorkshire and Humber Specialised Commissioning Group have advised PCTs to not fund Sativex.

"People with MS urgently need access to effective treatments and therapies - this decision is yet another example of the continuing postcode lottery that people with MS face."

Source: Evening Courier ©2010 Johnston Press Digital Publishing (06/08/10)

Almirall, S.A. and GW Pharmaceuticals plc today announced that the health authorities in Spain have granted regulatory approval for Sativex® Oromucosal Spray as an add-on therapy for the treatment of moderate to severe spasticity due to Multiple Sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication .

Prior to launch, Sativex® requires pricing and reimbursement approval from the Spanish Ministry of Health. This final approval process is expected to be completed during the 4th Quarter of 2010.

In addition, GW Pharmaceuticals has submitted an application under the European Mutual Recognition Procedure (MRP) to seek marketing authorization for Sativex® in other selected European member states, including the major commercial markets, France, Germany and Italy. The UK regulatory authority, the Medicines and Healthcare product Regulatory Agency (MHRA), which approved Sativex® in June 2010, has agreed to act as Reference Member State for the purposes of the MRP procedure.

The complete list of countries to which the MRP application is being made is currently being finalized and will be provided to the MHRA later this year.

“We are pleased to have received this regulatory approval of Sativex® in Spain and look forward to launching Sativex® later this year. Sativex addresses a significant unmet need offering relief to those MS patients who suffer from spasticity and associated symptoms who have been unable to obtain adequate benefit from currently available medication. We are also pleased to have commenced the regulatory process in other key European markets and look forward to additional approvals and launches in Europe next year.”, said Mr Luciano Conde, Chief Operating Officer at Almirall.

Mr Justin Gover, GW’s Managing Director, said, “Following the recent approval and launch of Sativex® in the UK, today’s approval in Spain and filing of the European mutual recognition submission marks the beginning of the international expansion of this product. Sativex® addresses an important unmet medical need for people with MS and together with our partners Almirall, we look forward to making the medicine available across Europe.”

Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS. Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.

Sativex® has been developed by UK-based GW Pharmaceuticals and will be marketed in Europe (except the UK) by Almirall, S.A.

Source: Almirall, S.A. and GW Pharmaceuticals plc (28/07/10)

A woman from Peterborough who went on hunger strike to get better medical help, including a cannabis-based drug, for her husband has won her battle.

Angela Cavill-Burch has cared full-time for her tetraplegic husband Terence ever since he got an infection three years ago.

She said he needed the drug called Sativex, normally only licenced for MS sufferers, to ease his chronic pain.

The drug is now being provided. Mrs Cavill-Burch's protest lasted six days.

She had called on NHS Peterborough Community Services (NHS PCS) for more support over a nine-month period.

The case was featured on BBC Look East on Monday and now NHS PCS has agreed to provide the drug Sanitex and reinstate physiotherapy as the medication works in conjunction with it.

Emergency night carers are also being provided for Mr Burch as an interim measure while full day and night time carers can be found.

Mrs Cavill-Burch said she was angry at how long the NHS PCS had taken to respond to her concerns.

"I should not have had to resort to such a drastic action to get people to listen to me," she told BBC Look East.

In a statement NHS PCS said: "A current review is now taking place to reassess these (the couple's) needs and to ensure that appropriate and effective care is in place in agreement with Mr Burch and Mrs Cavill-Burch."

Two meetings have already been set up for Mrs Cavill-Burch to meet with care agencies.

Source: BBC News © British Broadcasting Corporation 2010 (08/07/10)

A Birkdale mum, with multiple sclerosis, has hailed a new drug containing cannabis for easing the symptoms of her condition.

Fiona Caplan, 51, first tried out the medicine, Sativex, five months ago and found it aided her movements by relieving the stiffness in her legs.

The mother-of-one had to buy the drug privately as it was not available on the NHS, but now Sativex has been granted a license on the NHS and may soon be available on prescription.

Fiona, a former tax inspector, said: “I have tried most of the drugs prescribed for MS and none of them have worked.

“I really noticed the difference with Sativex, it relieved the stiffness in my legs and really helped me go about my day-to-day business.

“I have been off the medicine for two weeks now and the stiffness has come back.

“It was costing me £176 every four weeks for Sativex and I do hope I will now be able to get it on the NHS.”

Fiona, who lives in Birkdale with partner Barry, 52, and daughter Louise, 11, added: “The common misconception about the drug is that it gives users a high. Sativex doesn’t give you any sort of high.”

The spray is the first licensed medical drug containing whole cannabis plant extracts and is expected to become widely available to patients.

Source: Southport Visitor © 2010 owned by or licensed to Trinity Mirror North West & North Wales Limited. (07/07/10)

Abstract
OBJECTIVE: To determine the efficacy of Sativex (USAN: nabiximols) in the alleviation of spasticity in people with multiple sclerosis.

METHODS: The results from three randomized, placebo-controlled, double-blind parallel group studies were combined for analysis.

PATIENTS: 666 patients with multiple sclerosis and spasticity.

MEASURES: A 0-100 mm Visual Analogue Scale (VAS, transformed to a 0-10 scale) or a 0-10 Numerical Rating Scale (0-10 NRS) was used to measure spasticity. Patients achieving a > or =30% improvement from baseline in their spasticity score were defined as 'responders'. Global impression of change (GIC) at the end of treatment was also recorded.

RESULTS: The patient populations were similar. The adjusted mean change of the numerical rating scale from baseline in the treated group was -1.30 compared with -0.97 for placebo. Using a linear model, the treatment difference was -0.32 (95% CI -0.61, -0.04, p = 0.026). A statistically significant greater proportion of treated patients were responders (odds ratio (OR) = 1.62, 95% CI 1.15, 2.28; p = 0.0073) and treated patients also reported greater improvement: odds ratio 1.67 (95% CI 1.05, 2.65; p = 0.030). High numbers of subjects experienced at least one adverse event, but most were mild to moderate in severity and all drug-related serious adverse events resolved.

CONCLUSION: The meta-analysis demonstrates that nabiximols is well tolerated and reduces spasticity.

Source: Pubmed PMID: 20558502 & Mult Scler. 2010 Jun;16(6):707-14.(01/07/10)

GW Pharmaceuticals Plc's cannabis-derived medicine Sativex has been approved in Britain for treating spasticity in patients with multiple sclerosis, in a landmark decision for the small drugmaker.

The much-delayed product was finally granted a British licence on Thursday, an official from the Medicines and Healthcare products Regulatory Agency (MHRA) told Reuters on Friday.

The company later issued a statement confirming the move.

Clinical trials have shown GW's Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis (MS) in patients who do not respond adequately to existing therapies.

It became the world's first cannabis medicine to win regulatory clearance when it was approved in Canada in 2005 for neuropathic pain but its roll-out in Britain -- and other European markets thereafter -- is a larger sales opportunity.

GW and Germany's Bayer, which will market the drug in Britain, plan to hold a press conference on Sativex on June 21.

A green light from the MHRA had been expected before the end of June but confirmation of approval will still be a relief to investors, who have seen a series of delays with the product.

GW had originally hoped to win approval in 2003 for its drug -- which is extracted from marijuana plants grown at secret locations in the English countryside -- but the medicine has been hit by a string of regulatory delays in Europe.

GW said last month it also expected a regulatory green light in Spain shortly after the British approval, with other European countries following later.

Sativex will be sold in the rest of Europe outside Britain by Spanish drugmaker Almirall.

GW will receive a 10 million pounds ($15 million) milestone payment from Bayer as a result of British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain.

WILL NHS PAY FOR IT?

Questions remain about Sativex's commercial potential.

In particular, the rate of uptake in Britain will likely be limited until the National Institute for Health and Clinical Excellence (NICE) decides whether it should be reimbursed on the National Health Service (NHS).

Analysts at Piper Jaffray, which acts as adviser to GW, forecast that peak sales in MS spasticity could reach 121 million pounds in Europe and Canada combined.

The drug could also be used longer-term to help treat cancer pain worldwide, opening up a market opportunity potentially worth over $500 million in annual sales, according to the brokerage. However, marketing approval for this second use is not expected before 2013.

Shawn Manning, an analyst at Singer Capital Markets, said a green light for cancer pain in the United States would be a major commercial breakthrough.

"That's a real opportunity, that will be the big market -- that's the real target for this product," he said.

Source: Reuters © Copyright 2010 Thomson Reuters (18/06/10)

GW Pharmaceuticals expects its groundbreaking -- but much delayed -- cannabis-based medicine for multiple sclerosis to be approved in Britain before the end of June.

A regulatory green light in Spain is likely shortly thereafter, the British-based drugmaker said on Thursday, adding that regulators in both countries had agreed that all major and minor issues related to the application had been resolved.

The medicine, which is sprayed under the tongue, is to be marketed in Britain by Germany's Bayer and in the rest of Europe by Spain's Almirall.

Both marketing partners are now well advanced in preparations for the Sativex launch, GW said.

GW will get a 10 million pounds ($14.35 million) milestone payment from Bayer on British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain.

Clinical trials have shown GW's drug Sativex reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.

It became the world's first cannabis medicine to win regulatory approval when it was approved in Canada in 2005. Its roll-out in Britain, Spain and other European markets thereafter represents a much larger commercial opportunity.

Source: Reuters © Thomson Reuters 2010 (20/05/10)

Sativex Regulatory Update - UK and Spanish regulators confirm no major issues outstanding. Regulatory process now at advanced stage. Approvals expected Q2 2010.

GW Pharmaceuticals plc  today provided an update on the progress of its regulatory submission for Sativex® Oromucosal Spray for the treatment of the symptoms of spasticity due to Multiple Sclerosis. The regulatory submission was filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK acting as the Reference Member State.

The regulatory process has now reached “Day 150” of the decentralised procedure and both the UK and Spanish regulators have concluded that there are no major quality, safety or efficacy issues remaining to be resolved. Resolution is now required only of points of clarification related to finalisation of wording on the patient information leaflet. We expect this document to be reviewed by the regulators in the coming weeks.

Once the regulators have agreed final wording on the patient leaflet, the decentralised procedure can close and the process will enter its final phase. This final phase, known as the national phase, takes place separately in the UK and Spain and its purpose is to finalise local wording on product packaging and related documents.

GW therefore expects regulatory approval in the UK and Spain during Q2 2010.

Dr Stephen Wright, GW’s R&D Director, said, “This is a major milestone in the regulatory process for Sativex, and for GW’s future prospects. We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. This progress with Sativex also provides further validation of GW’s cannabinoid platform and the significant long term promise of GW’s portfolio of cannabinoid medicines.”

Sativex will be marketed in the UK by Bayer Schering Pharma, and in the rest of the European Union by Almirall S.A. Upon UK regulatory approval, GW expects to receive a £10m milestone payment from Bayer. A further £2.5m milestone payment is payable by Almirall following both regulatory and pricing approval in Spain.

Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.

Source: GW Pharamceuticals (18/03/10)

GW Pharmaceuticals plc announced that results from two clinical studies of Sativex® were presented at Europe's leading multiple sclerosis (MS) conference, the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place in Dusseldorf, Germany, from 9 - 12 September. The outcome of these MS spasticity studies were first reported by GW earlier this year.

Presentation of data from the Phase III MS spasticity trial was shortlisted by the conference for a prize. In this trial, 572 patients were enrolled into Phase A and 241 continued into Phase B. The authors conclude that “Sativex demonstrated a statistically significant and clinically relevant improvement in spasticity and was well tolerated in MS patients”. The primary endpoint was significantly in favour of Sativex (p=0.0002). In addition, the 30% responder analysis, spasm frequency, sleep disruption, Physician, Carer and Subject Global Impression of Change and Barthel Activities of Daily Living index were all significantly in favour of Sativex (p=0.0003, p=0.0046, p<0.0001, p=0.0045, p=0.0053, p=0.0234 and p=0.0067 respectively).

A separate presentation from this trial specifically assessed the value of a 4-week trial of treatment of MS spasticity with Sativex. The authors conclude that “a 4 week trial period with Sativex can effectively detect MS spasticity patients who will demonstrate positive outcomes in longer-term treatment”.

Data was also presented from a randomised withdrawal trial to assess the maintenance of efficacy after long-term treatment with Sativex for spasticity in MS3. In this trial, the authors conclude that “maintenance of long-term efficacy was demonstrated with Sativex compared with placebo in this randomised-withdrawal setting”. The primary endpoint, the time to treatment failure, was significantly in favour of Sativex (p=0.013). The Carer and Subject Global Impression of Change were also significantly in favour of Sativex (p=0.001 and p=0.017 respectively).

Dr Stephen Wright, GW’s R&D Director, said, “GW is leading the way in developing new treatment approaches targeted towards the relief of symptoms in people with multiple sclerosis. The studies reported at this prestigious conference show how Sativex can be personalised in a way that optimises the benefit obtained by people with otherwise treatment-resistant spasticity due to MS.”

Source: GW Pharmaceuticals plc (15/09/09)

GW Pharmaceuticals plc announced that it has filed a regulatory submission for Sativex® for the treatment of spasticity due to Multiple Sclerosis. This submission follows the recent announcement of a positive Phase III trial in this indication.

The regulatory submission has been filed in the UK and Spain under the European decentralised procedure. The UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State and has validated the application.

It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010.

Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.

Sativex will be marketed in the UK by Bayer HealthCare, and in the rest of the European Union by Laboratorios Almirall S.A.

Dr Stephen Wright, GW’s R&D Director, said, “We are pleased to have completed and filed the regulatory submission within a very short period of time of receiving the latest positive Phase III data. We look forward to working with the regulatory authorities in their review of the application.”

Source: GW Pharmaceuticals plc (20/05/09)

GW Pharmaceuticals has announced plans to submit an application to market its cannabis-based multiple sclerosis (MS) treatment, Sativex, in the UK.

This follows the announcement on Thursday of positive preliminary results for a Phase III study, which showed that in nearly three-quarters of people with MS taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity.

The Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose.

Source: GW Pharmaceuticals (16/03/09)

GW Pharmaceuticals plc today announces positive preliminary results from a pivotal Phase III double-blind randomised placebo-controlled study of Sativex® in patients with spasticity due to Multiple Sclerosis (MS), who have achieved inadequate spasticity relief with existing therapies. This study was requested by the UK regulator in order to gain approval in this indication and following today’s results, GW will file a regulatory submission in Q2 09.

This Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose. This study is the largest study GW has undertaken and recruitment was achieved in just ten months using 52 hospital sites in five countries – UK, Spain, Italy, Czech Republic and Poland.

The prospectively defined primary efficacy endpoint of the study - the difference between the mean change in spasticity severity of Sativex vs Placebo in Phase B - was highly statistically significantly in favour of Sativex (p=0.0002). The numeric difference between the two groups as measured on a Numeric Rating Scale was 0.84 units from a baseline of 3.89, greater than that achieved in previous studies. The difference between Sativex and placebo was also significant for a number of secondary endpoints. 74% of Sativex patients achieved an improvement of greater than 30% in their spasticity score over the entire study versus 51% on placebo (p=0.0003). In addition, statistically significant improvements were also seen in spasm frequency (p=0.005), sleep disturbance (p<0.0001), patient global impression of change (p=0.023), and physician global impression of change (p=0.005).

The study provides further evidence of Sativex’s reassuring safety profile. The adverse event data in this study was superior to previous Sativex studies – an improvement which resulted from the modified dose titration regimen employed in the study.

Following these positive results, GW will submit a regulatory application in Q2 09 in the UK and, subject to discussion with Almirall, other selected European countries. Upon approval, Sativex will be marketed exclusively in the UK by Bayer HealthCare and in the rest of Europe by Almirall.

Dr Stephen Wright, GW’s R&D Director, said: “This Phase III study is a resounding success and provides further evidence that Sativex provides meaningful efficacy for people with spasticity due to MS. In the last six months, GW has reported three positive Sativex studies incorporating a design modified from previous studies and we are delighted that this new approach is producing such consistent positive results. We will file a European regulatory submission in Q2 09 and look forward to progressing the review during 2009.”

Milestone Payment

GW also announces today that it has signed an amendment to the Sativex licence agreement with Almirall. This amendment provides for the potential milestone payment to be received following this study result to reach £8m. The £8m milestone will become due upon Almirall electing to include a country within their licensed territory (Europe excluding UK) as part of the forthcoming regulatory submission to the UK. This decision is expected to be made within the next month.

Justin Gover, GW’s Managing Director, said, “GW has a history of maintaining a strong financial position and this increased potential milestone payment represents an attractive opportunity to further consolidate this position. We are delighted by the ongoing support and enthusiasm of our licensing partners for the commercial potential of Sativex.”

Source: GW Pharmaceuticals plc (12/03/09)

GW Pharmaceuticals plc announced positive results from a placebo-controlled randomized withdrawal study of Sativex® in patients with spasticity due to Multiple Sclerosis (MS). This study was performed following regulatory guidance from the UK regulatory authority (MHRA) and provides evidence of long term efficacy to be included as part of the forthcoming European regulatory submission planned for Q2 09.

Separately, GW remains on track to report results of its Phase III MS Spasticity trial towards the end of Q1 09.

This randomized withdrawal study evaluated 36 MS patients with spasticity who had previously been taking Sativex on prescription. The mean duration of prior Sativex prescription use was 3.6 years. The patients were randomized to Sativex or placebo for 4 weeks in a double-blinded manner. During the randomized period, patients were not permitted to adjust their dose. The purpose of this blinded 4-week “randomized withdrawal” study was to assess the maintenance of spasticity relief in patients who remain on Sativex versus those who switch to placebo.

The prospectively defined primary efficacy endpoint of the study - the time to treatment failure - was statistically significantly in favour of Sativex (p=0.013). The difference between Sativex and placebo was also significant for the patient global impression of change (p=0.017) and the carer functional-ability global impression of change (p=0.001).  This means that the carer recognised that the patient’s spasticity became worse when they stopped taking Sativex - thus providing independent verification of the primary endpoint.

There was no evidence of a withdrawal syndrome in those patients who stopped Sativex, despite a very prolonged period on the medicine. Overall, there was a similar frequency and severity of adverse events in both the Sativex and placebo groups of patients, with more than 85% of such events being deemed mild or moderate in severity. 

In September 2008, GW reported positive results from a placebo-controlled randomized withdrawal study of Sativex in patients with neuropathic pain due to MS. The results reported today are from a study with a similar design but in patients with a different MS symptom. Taken together, these studies show that the efficacy of Sativex in the treatment of both neuropathic pain and spasticity due to MS is maintained in long-term use. 

Dr Stephen Wright, GW’s R&D Director, said: “This placebo-controlled study shows that Sativex provides meaningful long term efficacy for people with spasticity due to MS. These results will be an important new feature of the efficacy and safety data to be submitted in our next regulatory application. Separately, I am able to confirm that the pivotal Phase III trial in MS spasticity is on track to report results towards the end of Q1 09 and a regulatory submission is targeted for Q2 09.”

Source: GW Pharmaceuticals plc (24/02/09)

OBJECTIVES: To study possible psychopathological symptoms and cognitive deficits, abuse induction, as well as general tolerability and effects on quality of life, fatigue and motor function in cannabis-naïve patients with multiple sclerosis (MS) treated with a free-dose cannabis plant extract (Sativex).

METHODS: In an 8-week, randomized, double-blind, placebo-controlled, parallel group crossover trial, 17 cannabis-naïve patients with MS were assessed at baseline and at the end of the cannabis and placebo phases of the trial (each of 3 weeks) by means of Symptom Checklist-90 Revised, Self-rating Anxiety Scale, Multiple Sclerosis Functional Composite (of which 1 dimension is the Paced Auditory Serial Additional Test that was used to evaluate cognition), Visual Analogue Scale on health-related quality of life, Multiple Sclerosis Impact Scale-29, and Fatigue Severity Scale.

RESULTS: Postplacebo versus postcannabinoid scores showed that no significant differences could be detected on all the variables under study. A significant positive correlation was found between Delta-9-tetrahydrocannabinol blood levels and scores at the General Symptomatic Index and at the "interpersonal sensitivity," "aggressive behaviour," and "paranoiac tendencies" subscales of the Symptom Checklist-90 Revised. No serious adverse events, abuse tendencies, or direct withdrawal symptoms were reported. Increased desire for Sativex with secondary depression was reported in 1 subject.

CONCLUSIONS: Cannabinoid treatment did not induce psychopathology and did not impair cognition in cannabis-naïve patients with MS. However, the positive correlation between blood levels of Delta-9-tetrahydrocannabinol and psychopathological scores suggests that at dosages higher than those used in therapeutic settings, interpersonal sensitivity, aggressiveness, and paranoiac features might arise, although greater statistical power would be necessary to confirm this finding.

Source: Pubmed - PMID: 18978501 (12/11/08)

GW Pharmaceuticals has become the first drug company to gain approval to launch a cannabis-based medicine for multiple sclerosis sufferers.

The approval in Canada comes after six years of work for the company, which grows cannabis at a secret farm in southern England and turns it into an under-the-tongue spray, Sativex. And it marks a breakthrough for MS sufferers, who have long argued that cannabis relieves its symptoms, including pain and spasticity.

The Canadian authorities will allow GW, through its marketing partner, the German drug giant Bayer, to sell Sativex as a prescription painkiller, provided the company does additional clinical trials of the medicine over the next five years. GW must confirm the results of the studies to date, which have been promising, Health Canada said. The drug has so far been turned down by regulators in the UK, who say GW has not proven to their satisfaction that Sativex is effective.

Bayer will pay GW a £2m milestone as a result of Health Canada's approval.

Launch batches of Sativex are already in the country, and the drug will be available within weeks. Analysts disagree on the likely sales potential in Canada, which has 50,000 MS sufferers, half of whom suffer from the neuropathic pain Sativex has been approved to treat. Smoked cannabis is also available in Canada for medicinal use, and proposals for its decriminalisation are being debated.

Karl Keegan, an analyst at Canaccord, said: 'I think initially there will be a lot of hype over Sativex, but I suspect that people will want to smoke cannabis rather than use a mouth spray.'

How Sativex is seen

Canada: Health Canada has become the first regulator to approve a prescription medicine based on cannabis. Because so few MS sufferers say their pain can be treated effectively with existing medicines, it accelerated the approval process.

UK: GW has faced several setbacks in its dealings with the UK, despite the Home Office's backing for its plans to develop a cannabis-based MS treatment. The independent medicines regulator argued there was not enough data to support its launch as a painkiller. GW is appealing the ruling at a hearing.

Europe: European regulators will take their cue from the UK, so analysts believe that Sativex's full commercial potential can only be unlocked when GW has satisfied the regulator in its home country.

US: Originally thought opposed to cannabis-based medicines because it would represent weakness in its war on drugs. Now, though, GW believes regulators might be won round and will open talks this summer on how it might be allowed to trial Sativex in the US.

Source: NowPublic © NowPublic Technologies Inc. (14/10/08)

Cannabis products could soon be used legally for medical purposes in New Zealand, after an application by a leading drug company to market a liquid version for pain relief.

Medsafe is considering whether to allow the marketing and sale of cannabis spray, Sativex, after an application from its British maker.

It comes as the Government faces increasing pressure from some patients and scientists to legalise cannabis use to alleviate chronic pain for accident victims and some sufferers of multiple sclerosis and cancer.

Cannabis is a class C drug and cannabis preparations are class B drugs, but the Medicines Act allows the drug to be used with ministerial approval.

The Health Ministry said approval to use Sativex had been granted for three patients, and a further application was pending.

The spray, which is administered under the tongue, was developed by British firm GW Pharmaceuticals for multiple sclerosis patients and has been legal in Canada since 2005.

Rose Wall, the ministry's quality and safety manager, said the Medsafe application to market Sativex as a medicine was still being considered.

In a briefing paper to former health minister Pete Hodgson, issued by the ministry last year, officials said there was "sufficient evidence of safety and efficacy of cannabis in some medical conditions" to support consideration of compassionate, controlled use.

A group of medicinal cannabis users presented a petition with 3000 signatures to the health select committee in July, urging law reform for medical purposes.

Billy McKee, who appeared before the committee and is the director of GreenCross, a patients' medicinal cannabis support group, said patients who used cannabis medicinally faced many risks in buying it on the black market.

He smoked cannabis to control chronic nerve pain dating from car crash injuries sustained 15 years ago and would welcome Sativex if he could "easily access and afford it".

But he believed users could face costs of $150 to $300 weekly as it was not subsidised by Pharmac.

Mr McKee said users faced obstacles growing the drug, including arrest. His home had been burgled 20 times by thieves trying to remove plants.

Multiple Sclerosis Society national director Graham Billings said the agency supported the use of Sativex in New Zealand. "But until it's been made legal we can't really comment."

Otago University Pharmacology professor Paul Smith said the drug, which contained two cannabis strands - THC and cannabidiol - would not work for all chronic pain sufferers but initial results in multiple sclerosis patients showed about 30 per cent success, including reducing symptoms in some patients.

He believed the evidence was compelling and the drug should be allowed as, unlike cannabis plant and oil, it did not have to be smoked.

"The fact that it happens to be cannabis, from a pharmacologist point of view, is irrelevant."

GW Pharmaceuticals could not be contacted yesterday. In its application to Medsafe it says that in therapeutic doses, Sativex may produce side-effects "interpreted as a euphoria or cannabis-like high".

Source: stuff.co.uk © Fairfax New Zealand Limited 2007 (05/10/08)

GW Pharmaceuticals Plc announced today that a study of its cannabis-based pain killer Sativex has shown long-term efficacy in the treatment of neuropathic pain due to multiple sclerosis.

It is the first time that the long-term effectiveness of the drug had been demonstrated in a so-called placebo-controlled study, where it is tested against a dummy drug.

The news is also significant for the company because it bolsters hopes that it might gain approval for the drug as a treatment for spasticity associated with multiple sclerosis, because the trial is very similar to a late-stage trial that has been running at the request of regulators.

Stephen Wright, GW's R&D Director, said in a statement: "It is encouraging to note that if the difference between Sativex and placebo achieved in the results today are replicated in the ongoing Phase III MS spasticity study, this Phase III study will meet its objectives."

This study is due to report results in the first quarter of 2009 with a regulatory submission planned for the first half of 2009.

Source: Reuters © Thomson Reuters 2008 (08/09/08)

Sativex is a mouth spray extracted from cannabis plants. It's recently been approved in Canada for patients suffering from multiple sclerosis.

Ministry spokesman Bruce Atmore has told Parliament's Health Select committee they support Sativex being available in New Zealand.

He says it has a fast absorption that and with no involvement in the illegal market it's been chosen as the possible therapeutic to use.

Source: OneNews © Television New Zealand Limited (16/07/08)

Doctors will prescribe cannabis-based drugs to cancer, multiple sclerosis and AIDS patients in a planned NSW Government trial.

NSW Health Minister Reba Meagher will write to Federal Health Minister Nicola Roxon in the next few weeks for permission to import and trial a drug expected to be Sativex, which delivers cannabis compounds through an oral spray.

"While the Iemma Government is opposed to the legalisation of marijuana, we do support a therapeutic trial of a cannabis-based drug," a spokeswoman for Ms Meagher said.

"We want the trial to start as soon as possible. However the support of the Rudd Government would be needed to get TGA [Therapeutic Goods Administration] approval of the drug for use in the trial. We're hopeful the Government will approve."

The Australian Medical Association welcomed the trial.

"We believe medicinal cannabis may be of benefit in HIV-related wasting and cancer-related wasting," said chairman of the association's public health committee Dr John Gullotta, adding that it might also relieve nausea and vomiting in cancer patients undergoing chemotherapy.

The Cancer Council NSW welcomed the move.

Ms Meagher may also ask for approval for other cannabis-based drugs.

UK company GW Pharmaceuticals, the manufacturer of Sativex, grows cannabis then extracts cannabinoids CBD and THC. "The formulation is believed to enhance the pain relief of THC while modulating the unwanted psychotropic and other THC-related side effects, such as tachycardia [rapid heartbeat]," the company says.

GW Phamaceuticals said its pioneering cannabis-based medicine failed to show significant improvement in a final stage trial to treat neuropathic pain in multiple sclerosis (MS) patients.

GW said Sativex had a very high patient response rate in the trial but that the results narrowly failed to reach statistical significance due to an unexpectedly large placebo response.

"While valid, this indicates that the effect of Sativex is marginal, and we retain our doubts as to whether the product will ever prove a commercial success," KBC Peel Hunt analyst Paul Cuddon wrote in a research note.

Nomura analyst Gary Waanders described the result as disappointing.

GW's managing director Justin Gover said there was a "desperate need" for new pain treatments and Sativex had a "real role" to play.

"The commercial proposition is not in question," Gover told Reuters. "It is a hazard of pain research that placebo effects occur in clinical trials and Sativex has seen this with this study."

GW, which grows thousands of marijuana plants at a secret location in the English countryside, said it would have to carry out another study in neuropathic pain.

"What this means is we are not able to speed things up," a GW spokesman added.

The study was one of three final Phase III trials for Sativex taking place this year.

GW said its study into spasticity in MS patients, requested by the UK Regulator, was on track to report later this year. It also has a trial into cancer pain running in the United States also due in 2008.

"Our confidence in the outcome of our ongoing spasticity, cancer and pain studies is not affected by these results. Neither is our approach to gaining regulatory approval," Stephen Wright, GW's director of research and development, told an analysts' call.

Sativex, which is sprayed under the tongue, became the first cannabis-derived medicine to win regulatory approval when it was approved in Canada in 2005 as a treatment for neuropathic, or nerve, pain in MS patients.

But the drug has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.

Source: Yahoo! News © 2007 Yahoo (08/04/08)

The MHRA has taken this unprecedented step due to its view of the “huge public interest” in Sativex and the fact that approximately 1400 patients in the UK have so far received the medicine on prescription on a named patient basis. New patients continue to be prescribed Sativex every day. Hence, the MHRA considers that it is in the public interest for potential prescribers to have further information on the medicine.

Dr Geoffrey Guy, Chairman, said, “We welcome the MHRA’s appreciation of the public interest in Sativex and recognition of the extent of prescription use of Sativex in the UK. We continue to receive enquiries from UK physicians and patients on a daily basis and this report will serve to provide them with more information about the medicine and its use.”

Dr Guy added, “As we have previously announced, there is an outstanding efficacy issue to be resolved prior to full regulatory approval for Sativex in the relief of Multiple Sclerosis spasticity. This issue, detailed in the report, is being addressed through an additional Phase III clinical trial, which commenced recently.”

About Sativex
Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose oro-mucosal spray; each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials.  The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.

Sativex is already approved and marketed in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS, and for the relief of cancer pain.  Health Canada has approved Sativex under its Notice of Compliance with conditions (NOC/c) policy.

In the US, the lead indication for Sativex is cancer pain. On 26 November, GW and its US licensing partner, Otsuka, announced that the first US Phase II/III cancer pain trial had been initiated.  

GW has to date entered into three Sativex license agreements – with Otsuka in the US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK).

Source; GW Pharmaceuticals (14/12/07)

Twenty-eight patients completed the two-year, open-label extension trial. Investigators reported that patients required fewer daily doses of Sativex and reported lower median pain scores the longer they took the drug.

Authors also reported that drug’s administration was not associated with an increase in patients’ use of other analgesics – noting that several of the study’s participants reduced or ceased their use of pharmaceutical pain medications while taking Sativex. It has been estimated that more than one out of four MS patients suffer from neuropathic pain.

“[Sativex] was effective, with no evidence of tolerance, in … patients with central neuropathic pain and MS who completed two years of treatment,” investigators concluded. “The use of [Sativex], per se, did not lead to a … major increase … in the use of new analgesics, which over at least two years is … a further indirect measure of sustained effectiveness in [this] population.”

Previously reported data on the long-term efficacy of Sativex has shown the drug to decrease spasticity and bladder dysfunction in patients with MS.

NORML Senior Policy Analyst Paul Armentano called the extension trial results significant. “Multiple sclerosis is a chronic, degenerative disease; its symptoms become more severe over time,” he said. “Therefore, one would assume that patients would be increasing their daily drug administration in order to maintain their initial levels of pain relief. That they are not doing so indicates that patients are not becoming tolerant to the drug’s therapeutic effects. More importantly, this result may also be evidence that cannabinoids are, in fact, moderating the progression of this debilitating disease. “

In August, Canadian health officials granted regulatory approval to Sativex as an adjunctive treatment in adult patients with cancer pain. Canadian officials had previously approved the drug’s prescription use to treat MS-associated neuropathy.

Makers of the drug are seeking regulatory approval for Sativex in the United Kingdom, the European Union, and in the United States.

Source: Rochester Liberal (16/11/07)

The Journal of Clinical Therapeutics’ study indicated that Sativex is effective in the long term treatment of neuropathic pain in multiple sclerosis (MS) and that the benefits to the patient are gained without any requirement to increase the dosage over time.

Sativex is approved as a prescription medicine in Canada on the basis of a previous study which showed the medicine to be effective in short-term use; the latest study confirms that the treatment is effective in reducing pain and improving sleep over a longer period.

“The results announced today confirm that Sativex is able to provide substantial relief from pain for a long period of time to patients who have previously failed to obtain benefit from other available treatments,” stated Dr Stephen Wright, GW's Research & Development director. “The results add to what we know from short-term clinical trials, and we look forward to seeing the results of our ongoing pivotal study in the same condition in the first half of next year,” Dr. Wright added.

Source: Sharecast © Digital Look Ltd 1998-2007. (17/10/07)

The Medicines and Healthcare Regulatory Agency (MHRA) met last week to discuss Sativex, a medicinal form of cannabis.

It decided more clinical data was needed before the drug could be approved for treating muscle stiffness in MS patients.

Professor Mike Barnes, consultant neurologist at the University of Newcastle and a trustee of the MS Trust charity, said: "This decision leaves many people with MS little option but to resort to 'street' cannabis for relief from the painful and disabling symptoms of their condition.

"With Wednesday's announcement by the Prime Minister that re-classification of 'recreational' cannabis is being considered, this is even more worrying."

He said there was "compelling" evidence that Sativex helped a large proportion of people with MS.

On average, half the patients who tried the drug gained some benefit and there were no concerns.

Chris Jones, chief executive of the MS Trust, said: "It is a sad fact that the system imposes a 'one size fits all' model on a condition like MS. One size never fits all with MS - it is a hugely variable condition with variable responses to treatments. To deny some patients because the treatment doesn't help everyone is madness."

A fifth of 160 people surveyed by the MS Trust had reported a reduced need for supportive equipment or mobility assistance, said Mr Jones. Almost everyone taking part experienced an improvement in general life benefits.

"Sativex meets a currently unmet medical need in patients where there is no other conservative treatment option," said Mr Jones. "It is our view that Sativex should be licensed and become available on prescription." (22/07/07)

It said this follows constructive and detailed talks with regulatory authorities, in which they provided a clear path to approval for Sativex in the treatment of MS Spasticity.

The drug maker said it plans a further multiple sclerosis spasticity trial and the study is within budget for 2008.

The delay will not result in any increase in rate of research and development costs above current levels and will be financed from existing cash resources.

Source: AFX News Copyright AFX News Limited 2007. All rights reserved (20/07/07)

A new study shows Sativex - the first cannabis-based medicine permitted for use in Britain - works for as many as four out of five multiple sclerosis patients.

There was a 30 per cent improvement in symptoms for two out of five patients, according to a report in the European Journal Of Neurology.

Professor Christine Collin, of the Royal Berkshire And Battle NHS Trust, Reading, said spasticity, which causes spasms, is one of the most difficult MS symptoms to treat.

In the six-week study of 189 patients, half were prescribed Sativex and half given a placebo, or dummy treatment, while also taking their normal medication.

Sativex was significantly better than the placebo at relieving spasticity and uncontrollable muscle contractions.

The cannabis-based mouth spray was developed by British-based GW Pharmaceuticals after some MS patients broke the law to use the illegal drug, but is not yet licensed as a medicine in Britain.

However, patients can get Sativex if their doctor agrees to prescribe it on a 'named patient' basis, in which they take personal responsibility for using an unlicensed drug.

For several years, many of Britain's 100,000 MS patients have campaigned to be allowed to use cannabis to ease spasticity and pain.

'Effective relief of spasticity is extremely important to people with MS,' says Christine Jones, chief executive of the MS Trust.

'It is not only distressing and painful, but can have a negative impact on the quality of life. The results of this study add to the growing body of evidence that cannabis based medicines can be effective in helping to relieve this common symptom of MS.' GW is the only company legally to develop and produce cannabis-derived treatments.

The company grows 40,000 plants a year at a secret site in the British countryside.

Source: The Daily Mail(c) 2007 Daily Mail; London (UK). Provided by ProQuest Information and Learning. All rights Reserved (14/03/07)

Spasticity is one of the most common symptoms of MS, occurring in up to 84% of patients¹. Spasticity can severely impact quality of life and is one of the most difficult symptoms of MS to treat¹.

The study, a randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, saw Sativex or placebo added to existing anti-spasticity medication. Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05). Further, the addition of Sativex produced a more than 30% improvement in spasticity in 40% of the people treated¹.

Fern Andrews, a person with MS who has participated in clinical trials with Sativex, commented: "Spasticity can make the simple daily activities that most people take for granted, seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support. With Sativex, I'm able to choose how much I take depending on how bad my symptoms are - which is a real benefit".

Christine Jones, Chief Executive of the MS Trust said, "Effective relief of spasticity is extremely important to people with MS. Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

About the study published in the European Journal of Neurology:

The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial¹.

Sativex®:

Sativex (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.

Sativex has been developed by UK-based GW Pharmaceuticals plc. It is approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently being reviewed by European regulatory authorities for the symptomatic relief of spasticity in MS and, on approval, will be exclusively marketed by Bayer HealthCare in the UK.

References:

1. Collin C et al. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology, March 07.

Source: Medical News Today © 2007 MediLexicon International Ltd(28/02/07)

GW, which has a dispensation from the government to use cannabis for medical research, said it would receive milestone payments of up to $273 million (140 million pounds) from privately owned Otsuka, including a signature fee of $18 million.

It will also receive a royalty on sales of "high-teen to 20" percent, Managing Director Justin Gover told Reuters.

Sativex is an under-the-tongue spray, which is already on sale in Canada as a treatment for pain in multiple sclerosis.

It has incurred a number of delays in the UK but is currently being assessed by regulators in four European countries as a treatment to relieve spasticity in multiple sclerosis, with a decision expected later this year.

GW said it would start a Phase II/III clinical trial in the United States this year to assess Sativex as a treatment for cancer pain.

Otsuka, the world's 26th-biggest pharmaceutical company, will pay for this and any other U.S. trial of Sativex.

Gover said in a telephone interview that GW hoped to file the drug with U.S. regulators in 2010 and launch it in 2011.

Investec Securities, GW's broker, says Sativex can achieve peak annual sales in the United States of $390 million.

Otsuka specialises in central nervous system disorders. Its biggest product is schizophrenia drug Abilify, which is made and sold by Bristol-Myers Squibb .

GW said it was also in talks with Otsuka over a research collaboration for its other cannabis-based projects. Gover said he hoped to announce a deal this summer.

GW grows thousands of marijuana plants at a secret location in the English countryside.

Cannabis has a history of medicinal use dating back to ancient Chinese times. Queen Victoria, whose physician described it as "one of the most valuable medicines we possess", is said to have taken cannabis tincture for menstrual pains.

Source: Scotsman.com (c) Reuters 2007. All rights reserved. (14/02/07)

The results of the study in patients with neuropathic pain characterised by allodynia show that patients taking Sativex obtain clinically important improvements in their management of pain and quality of sleep. In comparison with placebo, statistically significant improvements were seen for key outcome measures, including a positive result in the primary analysis of patient response, the outcome measure recommended by regulatory authorities.

The results of the study in patients with painful diabetic neuropathy show that patients taking Sativex obtained substantial improvements in their pain, indeed among the highest level of response seen in the published literature. There was an abnormally large placebo response in this study, which means that the data are more difficult to interpret categorically.

Dr Stephen Wright, GW's R&D Director, said, "Neuropathic pain is one of the most difficult types of chronic pain to treat. These studies focused on particularly high need patients, who were already taking the best available pain treatments, and yet still suffered severe pain. Even in this most difficult to treat population, Sativex has produced improvements over and above current treatments that are highly meaningful to the everyday lives of patients."

These two studies form part of a programme of neuropathic pain trials conducted to date by GW and reinforce the large body of positive data already generated. These data contribute significantly to a future regulatory filing in the use of Sativex as a treatment for neuropathic pain. GW intends to continue to add to this evidence base.

This multi-centre double-blind, randomised, placebo-controlled parallel group study in 246 patients examined the effect of Sativex in patients with neuropathic pain characterised by allodynia. Allodynia is the occurrence of pain in response to a normally non-painful stimulus (e.g. clothes touching against the skin). It is often intense and can occur in patients suffering from a range of conditions that damage the peripheral nerves (e.g. nerve lesions, post-herpetic neuralgia). Patients in this study were being treated with a range of currently available analgesics, which were maintained during the course of the study.

The results of this study confirm the efficacy of Sativex. The responder analysis of the primary endpoint (the proportion of patients obtaining a clinically meaningful improvement in pain relief), was statistically significantly in favour of Sativex (p=0.03) for the full Intention to Treat (ITT) population. In addition, two of the key pain-related secondary efficacy endpoints, the Patient's Global Impression of Change (p<0.03) and the assessment of sleep quality (p<0.01), were also statistically significantly in favour of Sativex. All the other secondary efficacy endpoints were in favour of Sativex.

European and US regulators recommend a responder analysis of the primary endpoint in pain studies as the key assessment of outcome. This analysis was positive and confirms that Sativex produces a clinically important benefit over and above currently available treatments in a meaningful proportion of otherwise treatment-resistant patients. An additional analysis of the mean endpoint data was strongly in favour of Sativex and approached statistical significance.

This multi-centre double-blind, randomised, placebo-controlled parallel group study in 297 patients examined the effect of Sativex in patients with painful diabetic neuropathy. Patients in this study were being treated with a range of currently available analgesics, which were maintained during the course of the study.

In this study, patients taking Sativex showed a 30% mean improvement in pain scores, among the highest level of response seen in the published literature. One third of Sativex patients achieved over a 50% improvement in pain. However, the study results are difficult to interpret due to an abnormally large response in the placebo group. As such, although all outcome measures compared to placebo are in favour of Sativex, they do not reach statistical significance.

With regard to safety, the pattern of adverse events in both studies was similar to that seen in other Sativex studies.

Peripheral neuropathic pain forms part of a regulatory strategy to obtain approvals for Sativex across major markets in a range of indications, including MS symptoms, central neuropathic pain and cancer pain. Sativex is the subject of an ongoing regulatory application in four selected European countries for the symptomatic relief of spasticity in MS. Upon initial approval, it is intended to extend the MS spasticity indication into other European countries through the mutual recognition procedure. Since the rules do not permit a parallel regulatory application in neuropathic pain, GW's regulatory strategy for this indication is to continue to build the clinical evidence base whilst the MS spasticity regulatory process is ongoing. Hence, additional confirmatory trials have been under preparation for some months and ethics committee approvals obtained. With the benefit of today's results, the designs of the additional studies can be finalised prior to their commencement. These studies will further contribute to a future regulatory submission in neuropathic pain.

Sativex is approved and marketed in Canada for the symptomatic relief of central neuropathic pain in MS, and is the subject of an ongoing regulatory submission in Canada for the relief of cancer pain.

Source: Pharmabiz.com Copyright © Saffron Media Pvt. Ltd.

The MS spasticity study, which evaluated 337 patients over a 15 week period, showed a significant reduction in symptoms of spasticity in patients in the ‘per protocol' population (i.e. those patients who complied with the study protocol) with advanced MS who had severe levels of spasticity despite ongoing treatment with the best available anti-spasticity medications. In addition 36% of these patients reported at least a 30% improvement in their spasticity symptoms which was also statistically significant ¹ . The ‘intention to treat' population (all patients who entered the study, some of whom may have violated the protocol) showed a trend towards Sativex but this did not reach statistical significance. Sativex-treated patients also reported improvements in secondary endpoints such as sleep assessments at clinic visits; a timed 10 metre walk, quality of life measures, spasm severity and bladder symptoms. Benefits were also reported by carers who noticed overall improvements in the Sativex group.

Professor Christine Collin, lead investigator in the study and Consultant in Neurological Rehabilitation Medicine based at The Royal Berkshire and Battle NHS Trust, Reading commented, “This study shows encouraging results in a patient population with a high level of unmet medical need. It demonstrates that Sativex can reduce spasticity in these difficult to treat patients who have failed to gain enough improvement in their spasticity from the best currently available medication. Furthermore, when these results are pooled with a previous similar trial giving a total population of over 520 MS patients with spasticity, significant benefits in favour of Sativex were seen, in the whole intention to treat population.”

A second Phase III study presented at ECTRIMS and short-listed for a prize by the scientific committee, investigated Sativex in the management of bladder problems in people with MS. Bladder problems are a very common feature in up to 75% of people with MS experiencing dysfunction including increased frequency and urgency of urination and increased incontinence ². This study in 135 patients suffering with urinary incontinence, not wholly relieved by their existing treatment, demonstrated that Sativex had a positive impact on the symptoms of over-active bladder with 84% in the Sativex treated group vs. 58% of the placebo group reporting improvements in bladder dysfunction3. Statistically significant improvements were seen in nocturia (urination during the night), number of voids per day and patients' opinion of bladder symptom severity.

Sativex contains the cannabinoids delta9 -tetrahydrocannabinol (THC) and cannabidiol (CBD) and is formulated as an oromucosal spray which is administered by spraying into the mouth and allows flexible dosing which is ideally suited to the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in both studies ^1,3.

Sativex is licensed in Canada and has recently been submitted for regulatory approval in selected European countries.

Reference

^1. Collin C, Ambler Z et al. A randomised study of Sativex® in patients with symptoms of spasticity due to multiple sclerosis. Poster 412 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

². http://www.mssociety.org.uk/about_ms/symptoms/bladder/bladder_problems.html

³. de Ridder D, Constantinescu C et al. Randomised controlled study of cannabis based medicine (Sativex®) in patients suffering from multiple sclerosis associated detrusor overactivity. Poster 411 presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

SOURCE: GW Pharmaceuticals plc

GW said on Tuesday it had filed its Sativex treatment in the UK, Denmark, Spain and the Netherlands. The UK will be the main assessor, consulting with the other three countries, with a positive decision triggering approval in all four countries.

Sativex is GW's flagship product, and was first approved in Canada in April 2005 for neuropathic pain.

Its progress in the UK, however, has been much delayed.

GW initially hoped for approval by the end of 2003, but regulators asked for more data. Its prospects were further muddied in March, when GW reported mixed results from a clinical trial in multiple sclerosis (MS) patients with spasticity.

GW said after those results that it would talk to regulators about whether to file Sativex to treat this condition, or whether to wait for the results for two more trials in neuropathic pain later this year.

GW said its decision to file now was backed by Germany's Bayer, its marketing partner in the UK, and Spain's Almirall, its partner in the rest of Europe. Analysts said it was a sign that all three were optimistic of success.

"GW would not have made this submission without very careful consideration and support from partners and the regulators," Investec Securities analyst Ibraheem Mahmood said in a research note, estimating the European market for spasticity in MS patients at about 500 million pounds.

But Charles Stanley's Jeremy Batstone said there was no certainty that Sativex, an under-the-tongue spray, would be approved.

"Given past experience and the regulator's apparent desire to move the goalposts from time to time, the strategy should be regarded as high risk," he wrote in a research note.

GW grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.

Source: Reuters.co.uk

The company reported that results from Phase III studies into the cannabis-based medicine Sativex failed to reach statistical significance.

The trial was supposed to identify whether Sativex could be used to treat the relief of spasticity in people with Multiple Sclerosis.

"Analysis of the Intention to Treat population - incorporating all patients regardless of whether they complied with protocol - was in favour of Sativex but not to a degree that reached statistical significance," said GW Pharma.

The group said the study was one of a number of Phase III studies which are currently taking place to support approval of Sativex across Europe in a range of target indications.

Source: Yahoo Finance Copyright © 2006 ShareCast. All rights reserved.

Drug company GW Pharmaceuticals has received a boost ahead of a key decision on approving its cannabis-based medicine Sativex for sale in Britain, after regulators in Canada raised no new safety concerns following its recent launch there.

The Salisbury-based group said that the initial feedback from doctors and patients in Canada regarding its oral spray, aimed at multiple sclerosis patients, was positive.

Source: EdinbughNews.com

Sativex is a mouth spray that delivers medicinal marijuana. The metered spray is administered under the tongue or inside the cheek. It's concentrated to offer maximum pain relief with minimal marijuana buzz.

Health Canada was the first drug regulator to approve the medication for people with multiple sclerosis who can't get relief from traditional drugs.

The spray treats neuropathic pain in MS – nerve pain that can be triggered by touch, temperature or movement and is often difficult to treat.

"It feels like its sort of boring through your bones," said Janet Liston of Ottawa. "It's like it's inside your bone."

Liston has been taking Sativex for six months, which is how long it has been available in Canada.

So far, a few hundred people worldwide have used Sativex in clinical trials. They report side-effects that include some respiratory infections. A feeling of mild intoxication or dizziness was the most common.

"The side-effects are a lot less than smoking marijuana," said Dr. Jock Murray, an MS specialist in Ottawa. "A lot of people surprisingly don't want to get high, they want to get relief from their pain."

Sativex will be tested in the U.S. for people with cancer. In Britain, it's being tried in the treatment of diabetic neuropathy.

Dr. Mark Ware is prescribing medicinal marijuana for a variety of conditions at his pain clinic in Montreal. The results so far are mixed but encouraging, he said.

"I think the potential for drugs like Sativex and the family of cannabinoid products which are inevitably to follow is incredibly wide."

One of the drawbacks of Sativex is that it costs about $500 a month. Provincial drugs plans don't cover it but some private insurance plans do.

Source: CBC News © CBC 2006

The US FDA has accepted GW Pharmaceuticals' Investigational New Drug (IND) Application for Sativex, a cannabis-derived, oro-mucosal spray composed primarily of tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive cannabinoid, for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

As part of this IND, the FDA has agreed that GW Pharmaceuticals may proceed directly into pivotal Phase III clinical trials in the United States in this very seriously ill patient population.

This IND follows a pre-IND/end of Phase II meeting held with the FDA in June 2005. The FDA has reviewed the extensive quality, safety and efficacy data generated by GW on Sativex in Europe. In addition, the FDA has provided written guidance on the US Phase III trial protocol. The planned 250 patient, double-blind, randomised placebo controlled study will evaluate the effect of Sativex in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures, said a release here.

"A previous Phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients," says researcher, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City. "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role," he added.

GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-center double-blind, randomised, placebo-controlled parallel group study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine).

Sativex is a pharmaceutical product standardised by both composition and dose that is supplied in small vials as an oromucosal spray. Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells. These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.

In April 2005, GW announced that Sativex had been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.

Source: Pharmabiz.com Copyright © Saffron media Pvt. Ltd. (06/01/06 )

The U.S. research will study Sativex, a mist sprayed inside the mouth for absorption through mucous membranes, as a treatment for pain in patients with advanced cancer, GW said in an e-mailed statement Tuesday. The Food and Drug Administration accepted GW's application for a phase-three trial with 250 patients.

The study will evaluate how well Sativex relieves cancer pain and reduces use of opiates such as morphine and codeine.The company said it plans to apply for U.S. clearance in two to three years. GW won approval in April in Canada, where Sativex is marketed by Bayer AG for multiple-sclerosis patients, and has a special Home Office license for limited use in the U.K.

''Sativex seems to be a very promising treatment option for patients whose pain does not respond to current analgesics,'' said Nathaniel Katz, an assistant professor of anesthesia at Tufts University School of Medicine, in the company's statement. ''The clinical data thus far suggest that many patients may gain significant benefit from the use of Sativex.''

Sativex is derived from two principal compounds found in the cannabis plant, cannabidiol, also known as CBD, and Delta-9 Tetrahydrocannabinol, or THC, a psychoactive ingredient.

Source: Salt Lake Tribune © Copyright 2005, The Salt Lake Tribune.

Produced by The Medicines Management Team, NHS Greater Glasgow Primary Care Division, Gartnavel Royal Hospital, 1055 Great Western Road Glasgow G12 0XH .
Tel 0141 211 0327 Fax 0141 211 3826
Email: [email protected]

SATIVEX® FOR MULTIPLE SCLEROSIS:

Sativex® is a mouth spray containing two cannabis extracts which can now be imported on a named patient basis from Canada. It is not licensed within the UK. An application for a marketing authorisation was rejected as the CSM was not satisfied with efficacy data. The application was for use as “add on therapy for symptomatic relief of spasticity in patients with multiple sclerosis who do not respond adequately to other anti-spasticity medication”

NHS Greater Glasgow’s policy on management of unlicensed medicines states that GPs should not normally be expected to prescribe drugs which do not hold a UK marketing authorisation. There are additional
medico-legal issues and prescribers may not have enough information to use such drugs safely and effectively.

Prescribers of unlicensed products are responsible for the effects of that drug on patients. GPs should not prescribe this product. As it does not have a UK marketing authorisation, Sativex is non-Formulary and will not be considered by SMC or ADTC.

European authorities asked for two phase III trials of Sativex against neuropathic pain in the same patient group, Salisbury, England-based GW said today. Phase III is the last of three stages generally required for approval.

``One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS,'' said Stephen Wright, the company's head of research.

Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K.

Canadian regulators approved Sativex, administered as a mist sprayed inside the mouth, for use in neuropathic pain caused by nerve damage, in April 2005.

Source: Bloomberg.com Copywrite Bloomberg LP All rights reserved

GW Pharmaceuticals has agreed a deal for Spain's Almirall to market its cannabis-based medicine Sativex in European countries excluding the UK, sending its shares higher yesterday.

GW Pharma said it would receive a signature fee of £12m, within total potential milestone payments of £46m, and that it would maintain a significant share of long-term revenues.

Almirall is Spain's largest pharmaceutical company, with 2005 sales approaching €1bn, GW Pharma said.

Canada became the first country to approve Sativex for sale in April 2005 as a treatment for neuropathic pain in multiple sclerosis patients. It was expected to be approved in Britain by the end of 2003, but has suffered delays.

German drug maker Bayer is GW Pharma's marketing partner in Canada and the UK. "This is a useful addition to the Bayer deal," Erling Refsum, an analyst for Nomura, wrote in a research note. "Almirall is a more specialised European operation [than Bayer, but the deal shows] that there is significant interest in the product."

GW said the deal covered Sativex's use as a treatment for multiple sclerosis symptoms, neuropathic pain and pain associated with cancer. GW's shares rose 6p to 123.5p on the news.

The signature fee would boost GW Pharma's net cash balance to £22m, it said in a statement.

Cannabis has a long history of medicinal use, dating back to ancient China. Queen Victoria is said to have taken cannabis tincture for her menstrual pains.

It fell out of favour because of a lack of standardised preparations and the development of synthetic painkillers.

GW Pharma says it has got round the standardisation problems with its spray-based product, which also avoids the damaging effects of smoking the drug.

A woman developed mental health problems and later died after taking part in trials of a cannabis-based drug, an inquest has heard.

Diabetic Rene Anderson, aged 69 from Sheffield, was taken to hospital after starting to take Sativex to see if it would relieve pain she was suffering.

She died in March 2004 from acute kidney failure.

The continuing inquest is expected to have implications for the use of drugs derived from cannabis.

Useful relief

Mrs Anderson, a retired supermarket supervisor from Silkstone Close in Frecheville, had been taking part in a trial supervised by diabetes expert Dr Solomon Tesfaye.

He told the court he wanted to investigate whether cannabis could provide useful relief from the severe pain experienced by diabetic neuropathy sufferers.

Sativex, which is not yet licensed in the UK but has been granted a licence in Canada, had shown good results in multiple sclerosis patients, Dr Resfaye said.

He was first aware of Mrs Anderson's case when her family complained about her mental problems just days after her treatment began.

Admitted to hospital

The doctor said the dose of the drug, which is taken using an oral spray, was reduced but Mrs Anderson's daughter, Jackie Sadler, rang back two weeks later to tell of her mother's deterioration.

Sheffield coroner Chris Dorries heard how Mrs Anderson suffered a series of physical problems after she was admitted to hospital in October 2003, 23 days after starting to take Sativex

These included pneumonia which culminated in her death five months later.

The coroner said the purpose of the inquest was to examine what links there were, if any, between the experimental treatment and the physical deterioration which led to Mrs Anderson's death.

The inquest, which began on Monday, is expected to last five or six days.

Source: BBC News Online (13/12/05)

EXCLUSIVE by Priya Kotecha and John Pring, December 2005

The UK's drugs regulatory body is on the verge of sparking a huge row over the availability of a cannabis-based drug to disabled people.

Campaigners initially welcomed a decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to allow the cannabis-based spray Sativex to be imported as an unlicensed product into the UK for use by people with multiple sclerosis (ms).

MS groups and people with the condition welcomed the news.

Home Office minister Paul Goggins also backed the move.

The first applications for permission to import the drug for people with MS were submitted as DN went to press. The drug is expected to be available this month.

But the MHRA has since thrown the availability of the drug to thousands of other people who could benefit - especially those with arthritis and conditions that cause nerve pain - into serious doubt......

For the full story please click on the link above. 

GW announces that it has been informed by the Home Office that the Drugs Minister, Paul Goggins, has confirmed that Sativex® oromucosal spray, its cannabis-based medicine, may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.

In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfil the special needs of an individual patient under a physician’s direct personal responsibility. The basis on which Sativex may be imported, therefore, is the clinical judgement of doctors in relation to specific nominated patients.

This development follows the approval of Sativex by Health Canada in April 2005. The medicine has been available on prescription in Canada since late June.

More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued to GW a Wholesale Dealer’s (Importation from non-EU countries) Licence, and has not objected to the importation of Sativex under the regulations for importation of medicines unlicensed in the UK.

Sativex will remain a Schedule 1 controlled drug in the UK in line with stated government policy. This means that the prescribing of Sativex can only be permitted under Home Office licence. The Home Office will therefore be developing a licensing regime to fit these circumstances. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.

Clearance for supply on an unlicensed basis does not affect GW’s plans to seek full regulatory approval from the MHRA for Sativex in the UK. The Company is currently conducting a number of further Phase III trials and is still planning to submit an application for Marketing Authorisation to the MHRA during 2006. Only after such an approval is granted can the product be promoted in the UK.

(15/11/2005)

Sativex has already been licensed for use in Canada to relieve pain in people with MS.

The Home Office has now said the drug can be imported to the UK for individual patient's use.

MS charities welcomed the development as a step towards the drug being fully licensed for use on the NHS.....

For more on this story please click the link above.

To reduce her agony, Myrden, 41, has long taken dozens of prescription pills a day, including the powerful Dilaudin. Now, though, she has a new weapon in her arsenal: Sativex, billed as the world's first cannabis-based drug.

"I think it has good potential," says Myrden, squirting Sativex into her mouth from a small sprayer. "It's really fabulous that the government has taken marijuana seriously and is making a medicine of it."

For full article click the link above.

GW Pharmaceuticals said today it remained committed to winning European approval for its cannabis-based drug – despite a recent setback in the UK.

The company, whose shares halved when UK regulators turned down its appeal over the licensing of Sativex earlier this month, said it had “absolute confidence” in its prospects.

It came as GW launched the mouthspray in Canada for use by multiple sclerosis patients – the first time a cannabis-based medicine has ever been made available to the public.

GW also said pre-tax losses narrowed to £5.1 million in the six months to March 31, from a deficit of £6.9 million last time.

It described the launch of Sativex in Canada as a “transforming event”, adding: “We remain committed to securing approval of Sativex across Europe and elsewhere.”

The company said it was well-funded and had designed a programme to ensure it achieved these aims as soon as possible.

GW will have to produce more data before it is granted a licence in the UK to sell Sativex, which is designed for the relief of spasticity (involuntary muscle contractions) in MS patients.

Although it said the UK setback was “disappointing”, GW added it could now look forward to generating revenues from the treatment in Canada.

“We recognise and share the profound frustration of MS patients who will have to wait longer before Sativex may be licensed for prescription in the UK,” it added.

Source:  Scotsman.com

Sativex mouth spray isolates key medicinal ingredients from the marijuana plant A drug containing two of the active ingredients in marijuana may help people with multiple sclerosis (MS) who are suffering chronic pain due to malfunctioning nerves.

In MS, the body's own immune system repeatedly attacks the protective myelin sheath covering nerves in the brain and spinal cord. This results in a pattern of attack and remission of symptoms such as weakness, unsteady gait and vision problems. People with MS can also suffer neuropathic pain generated from the nerves themselves.

In 2001, Canada legalised the use of marijuana for severe pain or persistent muscle spasms in MS patients, but many doctors are reluctant to prescribe it. Those patients now have an alternative with the recent approval of Sativex, a mouth spray containing THC and CBD, two of the more than 60 related chemicals that make up the marijuana plant. It is believed these chemicals will provide the medical benefits of marijuana without the high.

Dr. William McIlroy, the national medical adviser for the MS Society of Canada, says in a statement that Sativex is "good news for the Canadian MS community" and "will likely be welcomed by the many people with MS whose quality of life has been further compromised with neuropathic pain."

In an interview, McIlroy adds he is "positive in a guarded sort of way" about the drug, explaining that "evidence to date in support of it is relatively limited."

Health Canada's approval of Sativex was based on the results of a four-week clinical trial involving 66 patients with MS-related neuropathic pain that was carried out in Great Britain, in which half received Sativex and the other half received an inactive spray. The Sativex group reported pain relief, less sleep disturbance and felt their condition had improved. But they also experienced more dizziness, nausea and fatigue.

Dr. Allan Gordon, a neurologist and director of the Wasser Pain Management Centre at Mount Sinai Hospital in Toronto, says he believes Sativex will become another valuable treatment option for MS-related pain. "It's not going to be the only part of the treatment for chronic pain, but it's going to be an important part."

Source: Macleans.Ca With files from The Medical Post.

GW Pharma today said that it has lost its appeal against a decision last year warranting new trials to test the safety of its cannabis-based drug Sativex.

The Committee on Safety of Medicines said in December 2004 that a further study in Multiple Sclerosis Spasticity would be required before the granting of a UK product licence for Sativex.

GW Pharma has since fought the decision to request a further study but was told yesterday that its appeal has lost. The Commission has determined that the evidence of efficacy of Sativex in MS Spasticity is not yet sufficiently compelling.

Sativex, derived from Cannabis, has already received regulatory approval in Canada in the treatment of pain in MS and is due to be launched soon.

Executive Chairman Dr Geoffrey Guy, said, “We are disappointed that the UK regulators consider that the efficacy data is not yet sufficiently compelling to make Sativex available to UK patients for the relief of MS Spasticity.”

Source : Sharecast.com

The world's first cannabis based medicine is expected to be approved by government regulators this summer.

'Sativex', an aerosol drug sprayed under the tongue, will be available on NHS prescription by the autumn after approval by the Medicines Control Agency (MCA).

The drug helps alleviate pain and spasms in MS.

GW Pharmaceuticals, who make 'Sativex', applied for a licence to sell the drug at the end of March. The MCA may approve the drug as early as June.

Ministers are said to be keen to license the drug, partly because of the embarrassment caused by people with MS breaking the law to treat their illness themselves.

GW Pharmaceuticals has been licensed to cultivate 40,000 pure marijuana plants at a secret location in southern England.

A study by the Joseph Rowntree Foundation shows that home cultivation of cannabis is now so widespread it may account for half of all cases related to the drug being drawn to the attention of police.

Source:  Sunday Times 13/04/03

Clinical trials being run by GW Pharmaceuticals on the benefits of cannabis are producing results of enough significance to make the legalisation of medical cannabis a much more likely prospect.

Tests on 70 British patients showed that an extract of the plant sprayed under the tongue significantly reduced pain, muscle spasms and bladder problems. 

In the phase two clinical trials patients have been given sprays containing cannabis or a placebo. The drug was sprayed under the tongues of participants so that it was absorbed into the bloodstream rather than swallowed or inhaled.

Dr Geoffrey Guy, chairman of GW Pharmaceuticals, said that he hoped cannabis would be prescribed legally by 2003. "Patients are clearly gaining benefit," he said. "These results provide enough confidence for us to increase the number of trial centres and the number of patients taking part. We are seeing a significant improvement in the quality of life for patients."

Source:  The Daily Telegraph

The interim findings of this small study are regarded as an important step towards the legalisation of cannabis for medical use.

Between 70-80% of 13 MS patients in a trail on cannabis spray say that it significantly reduces pain. Benefits found include not just pain relief, but a better quality of life, improved sleep, and a return to more active lives according to Dr Willy Notcutt of the pain relief clinic at the James Paget Hospital, Great Yarmouth.

Alan Milburn, the Health Secretary has stated the Government’s willingness to legalise the medical use of cannabis if trails show it can be of ‘clear benefit’. A larger trial on cannabis with 660 MS patients is now in progress, funded by the Medical Research Council.

Source: The Times & Daily Telegraph

Low doses of cannabis can relieve severe pain for people with MS, the largest clinical trial into the drug has found. Tests on three medicines derived from the plant helped 28 out of 34 patients.

GW Pharmaceuticals, the company given a licence by the Government to grow cannabis in Britain and run clinical trials, said none of the patients had responded well to conventional drugs.

Dr Willy Notcutt, of the James Paget Hospital, Great Yarmouth, who is running the trial, said: “Patients in this trial are suffering from severe pain. It dominates their lives."

“Given the previously intractable nature of their pain symptoms, the improvements provided by cannabis-based medicines are all the more remarkable."

“Many of those with chronic pain also suffer from a poor quality of sleep which over time can have profoundly negative effects on them and their families. By bringing about improvement in their sleep regime, as well as their pain, we can have a major positive impact on their quality of life.“

Patients were given three drugs containing cannabinoids, the active ingredients in the cannabis plant. One spray contained the cannabinoid CBD, another THC, and a third an equal amount of both.

Cannabis-based drugs worked better than a placebo for 28 of the patients, all of whom asked to continue on the drug. Twenty-five are still on the trial and have been taking the drug for two years. Only six felt no benefit. The drugs are administered with an inhaler under the tongue at low levels designed to avoid intoxicating effects.

Dr Geoffrey Guy of GW Pharmaceuticals said, “We believe there will be a market for all three medicines in pain treatment.”

The company will announce preliminary results from a bigger trial in November involving 400 people.

If cannabis-derived drugs get approved, they will be delivered by a smart inhaler which stops patients getting too high a dose.

Source: The Daily Telegraph, Tuesday October 1st 2002 

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