FDA accepts AVANIR's Neurodex for priority review

San Diego, USA-based AVANIR Pharmaceuticals says that the Food and Drug Administration has accepted for filing and review its New Drug Application for Neurodex (a combination of dextromethorphan and the enzyme inhibitor quinidine) for the treatment of involuntary emotional expression disorder (IEED), also known as pseudobulbar affect or emotional lability.

In addition, the Neurodex NDA will receive priority review by the FDA. AVANIR completed the submission of its NDA to the FDA on January 27, and expects the agency will take action on it by July 30.

The application is based on clinical data supporting Neurodex as being safe and effective in reducing the frequency and severity of unpredictable and uncontrollable episodes of IEED that occur as a consequence of neurological disease or injury.