The company submitted a new drug application in January 2006, seeking to market Zenvia for the treatment of involuntary emotional expression disorder (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.
Avanir said that until it is able to meet with the agency, it can not comment on the specifics of the approvable requirements. Additionally, the company said it cannot be certain that once it has met with the FDA that it will choose to continue with the development of Zenvia as previously planned.
Avanir has also initiated a phase III clinical trial with Zenvia as a potential treatment for patients with painful diabetic neuropathy.