This decision was made after a meeting with the FDA, where the agency requested that Avanir supplement the new drug application for Zenvia with additional clinical data to confirm that the proposed lower dose is effective and that it enhances the safety profile.
In preparation for the meeting, Avanir had submitted a briefing package with data from prior trials supporting a proposed lower-dose formulation of Zenvia.
As a result of this analysis, the FDA has requested that Avanir supplement the new drug application 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 dose. The company will also undertake certain preclinical and clinical pharmacology work to support the revised application for the lower dose of Zenvia.
Avanir anticipates being able to complete the clinical and non-clinical work over approximately the next two years.