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Avanir Pharmaceuticals Submits European Marketing Authorization Application for NUEDEXTA
Date:10/31/2011

ALISO VIEJO, Calif., Oct. 31, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that it has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA).

NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The marketing authorization application (MAA) is based on comprehensive clinical data from Avanir's phase 3 studies of NUEDEXTA in patients with PBA, plus data from the company's longer-term safety studies. The MAA filing triggers the initiation of EMA's validation process which is expected to be completed in November.  Once the MAA has passed validation, the scientific assessment and opinion review period will take a minimum of 210 days.

"The regulatory submission announced today represents another significant accomplishment for Avanir," said Joao Siffert, MD, senior vice president research and development at Avanir. "PBA affects millions of people across the globe and imposes a significant health burden on those suffering from this condition. The filing of this application with the EMA is an important step toward making NUEDEXTA available for PBA patients in Europe. The European medical community is looking forward to the day when they can offer the only therapeutic specifically approved for treating patients with PBA."

Financial Update

Based on preliminary results for the fourth fiscal quarter ended September 30, 2011, Avanir estimates gross revenue for NUEDEXTA of $4.3 million. This represents an approximate increase of 95% over the gross revenue for NUEDEXTA of $2.2 million in the third fiscal q
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SOURCE Avanir Pharmaceuticals, Inc.
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