Avanir reports FDA extends review period for Neurodex

New York, June 19 - Avanir Pharmaceuticals said the Food and Drug Administration has pushed back the deadline for its review of the company's new drug application for Neurodex for involuntary emotional expression disorder to Oct. 30, a 90-day extension.

The FDA said it needed the extra time to review the final study report of the recently completed QT research.

"While we are disappointed that there will be a delay in hearing about the status of the Neurodex NDA [new drug application], we believe the QT data provides added support to the safety profile of the drug," said Eric K. Brandt, president and chief executive officer of Avanir. "Avanir has had a strong and collaborative relationship with the FDA, and we will continue to work to achieve the approval of Neurodex for IEED [involuntary emotional expression disorder]."

Neurodex is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan.

Avanir is a San Diego-based developer of novel therapeutic products for the treatment of chronic diseases.

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