AVANIR RECEIVES APPROVABLE LETTER FOR ZENVIA

Avanir Pharmaceuticals announced it has received an approvable letter from the FDA for Zenvia (formerly called Neurodex) for the treatment of involuntary emotional expression disorder (IEED).

The company submitted a new drug application (NDA) in January, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that Avanir's application is approvable, subject to the FDA and Avanir reaching agreement on what additional safety and efficacy data will be required.

In accordance with FDA procedures, the company anticipates scheduling a meeting with the agency to discuss the letter. Until the company is able to meet with the agency, it can not comment on the specifics of the approvable requirements. Additionally, the company cannot be certain that once it has met with the FDA it will choose to continue with the development of Zenvia as planned.