Avanir's Neurodex for emotional expression disorder gets priority review

By Elaine Rigoli

Tampa, Fla., April 4 - Avanir Pharmaceuticals announced Tuesday that the Food and Drug Administration has granted priority review for its New Drug Application for Neurodex for the treatment of involuntary emotional expression disorder (IEED), also known as pseudobulbar affect or emotional lability.

IEED can occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling, causing a "short circuit," triggering episodes of involuntary emotional expressions, according to a news release.

"With no currently approved treatments for IEED, the agency's acceptance of our NDA represents an important step forward in the potential care for those suffering from IEED," president and chief executive officer Eric Brandt said in the release.

The application is based on clinical data supporting that Neurodex, a combination of dextromethorphan and low-dose quinidine, is safe and effective in reducing the frequency and severity of unpredictable and uncontrollable episodes of IEED, the release said.

San-Diego-based Avanir develops therapeutic products for the treatment of chronic diseases.

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