Avanir Pharmaceuticals Inc. (AVNR) announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration for Zenvia or dextromethorphan/quinidine for the treatment of pseudobulbar affect or PBA.
Avanir said that it expects the FDA to classify the response as a Class 2 resubmission1, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.
In the Approvable Letter of 2006, the FDA raised certain safety concerns related to the original Zenvia 30/30 mg dose formulation. After discussions with the FDA, the Company agreed to reformulate and conduct a confirmatory Phase III trial or STAR trial under a Special Protocol Assessment or SPA testing new lower dose 30/10 mg and 20/10 mg formulations of Zenvia designed to enhance the safety and tolerability profiles while maintaining clinically meaningful and statistically significant efficacy.
The company said that the filing consists of several modules including the final study reports from the double blind and open-label portions of the STAR trial, cardiovascular and respiratory safety white papers, an integrated safety database of subjects exposed to the components of Zenvia at any dose over the past 10 years of development, the company's proposed package insert and a proposed REMS program.
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