AVANIR's NUEDEXTA for pseudobulbar affect now available by prescription

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AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) is now available by prescription in the United States. NUEDEXTA is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for pseudobulbar affect (PBA).  PBA is a neurologic condition causing involuntary, sudden and frequent episodes of laughing and crying in patients with certain underlying neurologic diseases or injuries. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state.

"We are very pleased to announce that NUEDEXTA is now available for prescription through retail pharmacies across the country," said Keith Katkin, AVANIR's President and CEO. "After years of hard work and perseverance, the availability of NUEDEXTA is an important milestone for the many patients in the United States suffering from PBA who now have access to a safe, effective treatment."

"It's promising to see new therapies like NUEDEXTA coming on to the market, providing patients with additional tools to help manage some of the disabling conditions associated with brain injuries and other neurologic conditions," said Susan H. Connors, President and Chief Executive Officer of the Brain Injury Association of America. "We look forward to seeing more trends like this emerge."

In conjunction with its availability in pharmacies nationwide, AVANIR's sales force will commence promotion on February 7, 2011 to neurologists, psychiatrists and other physicians who treat patients with PBA secondary to underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) , traumatic brain injury (TBI), stroke, Parkinson's disease and certain other neurologic diseases.

The national launch of NUEDEXTA is being supported by 75 specialty sales representatives, the majority of whom have significant prior experience selling CNS therapies to the neurology and psychiatry audiences. Additionally, the Company has built a managed markets account team that is now interfacing with formulary decision makers from key Medicare Part D plans, commercial insurers, pharmacy benefit managers and drug wholesalers to maximize patient access to NUEDEXTA.

To support the availability of NUEDEXTA for all patients with PBA, AVANIR has initiated several patient support services such as a reimbursement counseling hotline and a co-pay assistance program. These NUEDEXTA patient support services are intended to help people who suffer from PBA navigate potential administrative insurance issues as well as to reduce out-of-pocket costs for eligible patients.  

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