Avanir Pharmaceuticals Pre-Announces Preliminary Fiscal 2012 Fourth Quarter Results And Provides Clinical Study Update

Joao Siffert, MD, senior vice president of R&D at Avanir, said, "Dosing of the first human subject with AVP-786 is an important milestone as we work to develop this next generation compound. One goal of this study is to assess if deuteration of dextromethorphan in AVP-786 confers metabolic properties similar to the combination of dextromethorphan with quinidine. We believe data from this study will be informative for the selection of one or more quinidine sparing formulations of AVP-786 to take forward into further clinical development."

About AVP-786

The incorporation of deuterium into specific molecular positions of dextromethorphan, resulting in AVP-786, maintains the pharmacology of dextromethorphan and provides significantly enhanced resistance to CYP2D6 metabolism and improved plasma exposure in preclinical testing.

About NUEDEXTA

NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), 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 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 typically occur out of proportion or incongruent to the underlying emotional state.

Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20/10 mg capsules can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA which may lead to serious side effects. Adjust dose or use alternate treatment of the other medication when clinically indicated.

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