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Avanir Pharmaceuticals Achieves Commercial Milestones & Provides Clinical Updates

ALISO VIEJO, Calif., Sept. 20, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced several business updates. The highlights are being provided in connection with the company's presentation today at the UBS Global Life Sciences Conference in New York City.

Highlights include:
  • Exceeding 10,000 total NUEDEXTA® prescriptions for the month of August.
    • NUEDEXTA prescriptions of 10,710 in August represent 9% growth over the month of July.
    • August monthly prescriptions annualize to a gross NUEDEXTA sales run-rate of over $65 million.
    • Achieved record weekly prescriptions of 2,552 for the week-ending September 7, 2012
  • Presentation of interim PRISM Registry data at the 16 th Congress of the European Federation of Neurological Societies (EFNS) in Stockholm Sweden. Dr. Jonathan Fellus' presentation entitled The PRISM Registry: A Novel Research Tool to Estimate the Prevalence of Pseudobulbar Affect highlighted data showing that of the 4,349 enrolled patients, approximately 37% of all participants had PBA symptoms as measured by a CNS-LS score ≥13.
  • Strong interest and robust recruitment in the AVP-923 phase II clinical study of agitation in Alzheimer's disease demonstrated across eight sites currently recruiting patients.*
  • Recent submission of responses to the European Medicines Agency (EMA) for the NUEDEXTA Marketing Authorization Application (MAA). The submitted responses address the "Day-120" questions posed by the EMA in March 2012. Based on the review timelines, Avanir expects to receive an opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the NUEDEXTA MAA by the first calendar quarter of 2013.

A live webcast and 30-day archive of the presentation given at the UBS Global Life Sciences Conference will be available at

About Pseudobulbar Affect

People with pseudobulbar affect (PBA) have sudden outbursts of involuntary crying or laughing, even though there may not be anything particularly sad or funny to trigger those emotions. Many people who suffer from PBA describe their episodes as uncontrollable, exaggerated, or different from their true feelings. PBA may occur when certain neurologic diseases or injury damage the areas of the brain that control normal expression of emotion. This damage can disrupt brain signaling, causing a "short circuit" and triggering episodes of involuntary crying or laughing. PBA can occur in people diagnosed with a variety of otherwise unrelated neurologic conditions such as Lou Gehrig's disease (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease. For more information about PBA, please visit


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.

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