AVANIR TO CONDUCT ADDITIONAL STUDIES TO SUPPORT ZENVIA NDA

Avanir Pharmaceuticals announced it has met with the FDA to address concerns expressed in the agency's October 2006 approvable letter for Zenvia as a treatment for involuntary emotional expression disorder.

In preparation for the meeting, Avanir submitted a briefing package outlining its responses to questions contained in the approvable letter. At the core of the briefing package was sophisticated pharmacokinetics/pharmacodynamics modeling based on data from prior trials supporting a proposed lower-dose formulation of Zenvia (dextromethorphan/quinidine).

In addition, the package contained data supporting the lower-dose formulation of Zenvia, which contains less quinidine (10 mg) in order to reduce QT intervals below the 5-millisecond threshold.

The FDA has requested that Avanir supplement the new drug application (NDA) for Zenvia with additional clinical data to confirm that the proposed lower dose is effective and that it enhances the safety profile. The FDA proposed a single well-controlled study. The company will also undertake certain preclinical and clinical pharmacology work to support the revised application.

"We will begin to work with the FDA on the final trial design and protocol and are pleased to be moving this important drug candidate forward," Randall Kaye, senior vice president and chief medical officer, said.