CHMP recommends approval of NUEDEXTA for treatment of pseudobulbar affect

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) 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.

"The positive opinion from CHMP and recommendation for a broad PBA label for NUEDEXTA is a key step in the regulatory process toward having the first and only evidence-based treatment for PBA approved in the European Union," said Dr. Joao Siffert , chief scientific officer of Avanir. "We will continue to work with the European Medicines Agency and the European Commission toward the marketing authorization so that patients suffering from PBA have ready access to NUEDEXTA in Europe."

PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and disruption in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing.

"PBA causes substantial medical and social burden," said Professor Kevin Talbot , director of the Oxford Motor Neuron Disease Care & Research Center. "Appropriate management of this debilitating condition can have meaningful clinical benefits for patients. Once available in Europe, NUEDEXTA will offer an important therapeutic option to effectively manage PBA."

The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, NUEDEXTA would be approved for marketing in all 27 member states of the European Union plus Iceland and Norway.