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.

Direct Tel during working hours (9am-12:30pm, 1:30-5pm)	01635 563116
Direct Fax	01635 563657
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E-mail	medical.science@bayer.co.uk
Urgent Enquiries (between 12:30 - 13:30)	07876 577704
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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: prescribing@gartnavel.glacomen.scot.nhs.uk

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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