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AVANIR Pharmaceuticals Announces FDA Approval of NUEDEXTA™
Date:10/29/2010

sed to bring the first proven treatment option to the many patients in the U.S. living with PBA.  I would like to thank FDA for working closely with us to make NUEDEXTA available."

"PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation," said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies evaluating NUEDEXTA. "As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity."

NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).  NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo.  The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.

Conference Call

AVANIR will hold a conference call and audio webcast on November 1, 2010 at 8:15 a.m. To participate in the conference call, please dial 877-558-3407 (domestic) o
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SOURCE AVANIR Pharmaceuticals, Inc.
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