FDA Approves NUEDEXTA Capsules for Pseudobulbar Affect

AVANIR Pharmaceuticals, Inc.

AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.  

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.    

"The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition," said Keith Katkin, president and chief executive officer of Avanir.  "The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."

"This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA," said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National MS Society. "For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families."

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