Nuedexta

Treatment for Pseudobulbar Affect

Update: Nuedexta (dextromethorphan and quinidine) Now FDA Approved - October 29, 2010

Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder

SAN DIEGO, October 31, 2006 - Avanir Pharmaceuticals announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zenvia (formerly referred to as Neurodex) for the treatment of involuntary emotional expression disorder ("IEED"). The Company submitted a new drug application ("NDA") in January 2006, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that Avanir's application is approvable, subject to the FDA and Avanir reaching agreement on what additional safety and efficacy data will be required. In accordance with FDA procedures, the Company anticipates scheduling a meeting with the agency to discuss the approvable letter. Until the Company is able to meet with the agency, it can not comment on the specifics of the approvable requirements. Additionally, the Company cannot be certain that once it has met with the FDA, that it will choose to continue with the development of Zenvia as previously planned.

"We will be working closely with the agency to determine the next steps required for the drug to receive marketing approval," said Eric K. Brandt, President and Chief Executive Officer of Avanir. "We believe Zenvia can significantly improve the lives of patients, their families and their caregivers by reducing the emotional and social toll taken by IEED."

For more information, please visit Avanir Pharmaceuticals

Posted: October 2006

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