AVANIR'S NEURODEX NDA ACCEPTED FOR PRIORITY REVIEW

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Avanir Pharmaceuticals has announced that the FDA has accepted for filing and review its new drug application (NDA) for Neurodex for the treatment of involuntary emotional expression disorder (IEED), also known as pseudobulbar affect or emotional lability.

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 that occur as a consequence of neurological disease or injury. Two controlled, multicenter Phase III clinical trials were conducted, one in amyotrophic lateral sclerosis patients with IEED, and the other in multiple sclerosis patients with IEED.