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Treatment for Pseudobulbar Affect

Update: Nuedexta (dextromethorphan and quinidine) Now FDA Approved - October 29, 2010

Avanir Submits NDA for Neurodex

SAN DIEGO, June 30, 2005 - Avanir Pharmaceuticals (AMEX:AVN) announced that the company has submitted the final modules of a "rolling" submission of the new drug application (NDA) for Neurodex, an investigational new drug, to the U.S. Food and Drug Administration (FDA) as an electronic common technical document (eCTD). Avanir is seeking approval to market Neurodex as a treatment for pseudobulbar affect (PBA), also known as pathological laughing and crying, emotional lability, and emotional incontinence.

Pseudobulbar affect is a neurological condition characterized by the disinhibition or loss of control of the motor expression of emotion. Symptoms of PBA include uncontrollable crying or laughing that is out of context with the social setting. It can be severe, unremitting, and persistent. PBA occurs secondary to neurological disease or injuries including amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, multiple sclerosis (MS), stroke, traumatic brain injury, and dementias such as Alzheimer's disease. If approved, Neurodex would be the first drug indicated to treat PBA.

"Completing this NDA submission marks a key milestone in Avanir's commitment to develop treatments for chronic conditions such as PBA," said James E. Berg, Vice President of Clinical and Regulatory Affairs at Avanir. "The Neurodex NDA submission is supported by a data package that, as previously reported, shows the consistency with which Neurodex helps patients address PBA symptoms."

The NDA for Neurodex contains data from two controlled, multicenter Phase III clinical trials: one conducted in ALS patients and the other in MS patients. Data was also submitted from its open-label clinical study evaluating the safety of long-term exposure to Neurodex in patients with PBA associated with a variety of neurological disorders. Following the NDA submission, Avanir will submit additional safety data from the ongoing open-label clinical study, including a 120-day safety update required by FDA regulations.

"Neurological disorders and brain injuries can affect patients' lives in devastating ways, but one consequence, PBA, is frequently overlooked or misdiagnosed," said Hillel Panitch, MD, Professor of Neurology at the University of Vermont College of Medicine and Director of the Multiple Sclerosis Center at Fletcher Allen Health Care in Burlington, Vermont. "Even though its hallmark characteristics -- uncontrollable laughing and crying -- were described by Charles Darwin more than 130 years ago, the mechanisms underlying PBA are still not clear. However, the debilitating effects of the condition have been well documented. PBA can be seriously disabling in social or occupational settings, adversely affecting the quality of life for patients."

"With no drug currently approved for the treatment of PBA, this NDA submission represents an important step forward in the potential care and treatment of patients suffering from pseudobulbar affect as a result of devastating underlying neurological disease or injury," concluded Dr. Panitch.

Avanir Pharmaceuticals is a pharmaceutical company focused on developing and commercializing novel therapeutic products for the treatment of chronic diseases. Avanir's product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. Avanir's preclinical research and development program for inflammatory disease is partnered with Novartis. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores.
For more information, please visit the Avanir website.

Posted: June 2005

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