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

r 706-679-1941 (international) and reference the access code 22130601. A live audio webcast of the conference call will be available by visiting AVANIR's website at www.avanir.com.  To listen to the live presentation, please go to AVANIR's website prior to the start of the presentation to register, download and install the necessary software. An archive of the conference call will be available on the Company's website for 30 days.

About NUEDEXTA

NUEDEXTA™ is the first and only FDA-approved treatment for pseudobulbar affect (PBA).  NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.  NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.  

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).  PBA occurs secondary to a variety of otherwise unrelated neurological 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.  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 signi
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SOURCE AVANIR Pharmaceuticals, Inc.
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