Avanir Pharma Wins Positive CHMP Opinion for Approval of NUEDEXTA in Europe

Avanir Pharmaceuticals, Inc.

today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for NUEDEXTA^® (dextromethorphan hydrobromide and quinidine sulfate), recommending NUEDEXTA be approved for the treatment of pseudobulbar affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules.