Avanir Meets With FDA on Emotional Control Drug

Avanir Pharmaceuticals (www.avanir.com) of Aliso Viejo, Calif., recently met with the U.S. Food and Drug Administration to respond to the agency’s concerns about Zenvia (formerly called Neurodex), the company’s product for “involuntary emotional expression disorder” (IEED, also known as “pseudobulbar affect”).

Zenvia is a combination of quinidine and dextromethorphan and was developed to help patients regain control of unwanted episodes of laughing or crying that can occur in some neurological disorders, including amyotrophic lateral sclerosis (ALS). In October, the FDA raised concerns about the safety of Zenvia and declined to approve it.

Avanir said it will conduct another clinical trial with a new formulation of Zenvia that reduces amount of quinidine per dose from 30 milligrams to 10 milligrams. The company says it believes the drug will still be effective.

Check MDA’s and Avanir’s Web sites for details as they become available.