AVANIR Pharmaceuticals (NASDAQ:AVNR) announced the Company has met with U.S. Food and Drug Administration (FDA) officials to address concerns expressed in the FDA’s October 30, 2006 approvable letter for Zenvia(TM) as a treatment for involuntary emotional expression disorder (IEED) and to present AVANIR’s proposed strategy to gain approval for Zenvia for this indication.
In preparation for the meeting, in January AVANIR submitted a briefing package outlining its responses to questions contained in the approvable letter. At the core of the briefing package was sophisticated PK/PD modeling based on data from prior trials supporting a proposed lower-dose formulation of Zenvia, as well as detailed statistical analysis addressing questions concerning the secondary efficacy endpoint in a prior trial. There was support for the Company’s modeled lower Quinidine dose (10 mg) formulation to reduce QTc intervals below the 5 msec threshold as well as the Company’s statistical analysis presented on the secondary efficacy endpoint agreeing that Zenvia at the 30/30 dose had demonstrated efficacy in its controlled clinical studies.
As a result of this analysis, 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 to test lower exposure of dextromethorphan with the agreed-upon lower Quinidine dose. The Company will also undertake certain preclinical and clinical pharmacology work to support the revised application for the lower dose of Zenvia.
“We are very pleased with the outcome from our meeting with the FDA,” said Randall Kaye M.D., Senior Vice President and Chief Medical Officer for AVANIR. “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.”
AVANIR expects to begin the required activities addressed in the FDA meeting immediately. The Company anticipates being able to complete the clinical and non-clinical work over approximately the next two years.