Priority review for Avanir involuntary expression drug

The FDA grants priority review status to products that, if approved, would address an unmet medical need or are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. The company expects the FDA to take action on the new drug application (NDA) by July 30, 2006.

“We are very pleased that the FDA has accepted for filing the NDA for Neurodex, and that our submission will receive priority review,” said Eric Brandt, Avanir’s president and CEO. “With no currently approved treatments for IEED (involuntary emotional expression disorder), the agency’s acceptance of our NDA represents an important step forward in the potential care for those suffering from IEED.”

Involuntary emotional expression disorder 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.