Avanir Pharmaceuticals Announces Landmark 'PRISM' Pseudobulbar Affect Patient Registry
Registry will Assess Relationship between PBA and Quality of Life
ALISO VIEJO, Calif., May 4, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc.(Nasdaq: AVNR) 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."
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. For more information about PBA, please visit www.PBAinfo.org.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
About Novella Clinical
Novella Clinical, Inc. is a full service contract research organization headquartered in Research Triangle Park, N.C. For more than a decade, Novella has served as an active partner to the oncology, biopharma and medical device industries. As the first global eCRO, Novella integrates deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process. For more information, visit www.novellaclinical.com.
AVANIR™ is a trademark owned by Avanir Pharmaceuticals, Inc.
©2011 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the launch of a registry study are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the ability to enroll clinical sites, the ability to enroll patients into the registry, the ability to define the prevalence of PBA, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
SOURCE Avanir Pharmaceuticals, Inc.
May 04, 2011