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Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
Date:4/26/2013

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.

For further details about the CHMP opinion, please visit the EMA website.

About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, 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 approved in the U.S. for the treatment of PBA in the 20/10 mg dose strength.

NUEDEXTA Important Safety Information
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 ty
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SOURCE Avanir Pharmaceuticals, Inc.
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