Pseudobulbar Affect (Emotional Lability)

This can be described as an excessive emotional response to a minor stimulus, e.g. to soap operas on TV, a song on the radio, or a movie scene.It is often transient but can be embarrassing.

Sometimes a person will act or say something in an inappropriate manner in any given situation; again, suddenly laughing for no apparent reason, even to yourself, or suddenly bursting into tears is common- this is known as the pseudobulbar effect and is sometimes treated with carbamazepine and SSRI’s - anti-depressants such as Prozac®

Zenvia, a new drug for Pseudobulbar Affect (Emotional Lability), is expected to be approved by the FDA in the first half of 2010.

Landmark 'PRISM' pseudobulbar affect patient registry announced

Avanir Pharmaceuticals, Inc. today announced the PRISM patient registry, the first patient registry to further quantify the prevalence and quality of life impact of pseudobulbar affect (PBA) in patients with a variety of underlying neurologic conditions.

Nearly two million Americans with existing neurologic disease or brain injury are estimated to be living with the added burden of PBA, a condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or are incongruent to the patient's underlying emotional state. Until now, the complexity of those distinct conditions has served as a barrier to widespread collaboration among treating physicians.

The PRISM registry aims to define the prevalence of PBA in patients with the associated underlying neurologic conditions of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease. Avanir anticipates recruiting 10,000 patients into the registry across approximately 500 sites in the U.S. Avanir is working with Novella Clinical as the company's contract research organization and expects enrollment to initiate in May and continue for at least six months. Data collected through PRISM will serve as the basis for continued clinical research efforts surrounding PBA.

"The PRISM registry will assess the relationship between PBA and quality of life among affected patients," said Randall Kaye, M.D., chief medical officer of Avanir. "In addition, data collected across multiple sites in the U.S. will allow participating investigators to compare the incidence of PBA within their practice to regional and national numbers. At Avanir, we believe a better understanding of PBA prevalence is positive for physicians, patients, and caregivers alike, and are thrilled to initiate what will ultimately be the largest PBA clinical registry ever performed."

"As a physician working directly with patients impacted by various neurological conditions and PBA, the PRISM registry represents a tremendous step forward in helping to document the true impact of this misunderstood and under-diagnosed condition," said Jonathan Fellus, M.D., medical director of rehabilitation, Meadowlands Hospital Rehabilitation Institute in New Jersey. "For too long, patients and their families have battled involuntary, sudden, and frequent episodes of laughing and/or crying without the knowledge and comfort that this condition is a treatable condition that many other patients are living with and managing on a daily basis."

About PBA
Patients suffering from existing neurologic disease or brain injury may also suffer the added burden of pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition-such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones.

Source: Avanir Pharmaceuticals, Inc (04/05/11)

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