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Complete response for Pozen’s Trexima

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has accepted Pozen's amended response to an "approvable" letter the firm received Aug. 1 for its migraine candidate Trexima (sumatriptan and naproxen sodium). The agency deemed the application complete, setting the clock for an April 15, 2008, user fee date, Pozen announces Nov. 1. The company submitted the NDA Aug. 8, 2005. GSK will market Trexima upon approval under a June 2003 agreement (1Pharmaceutical Approvals Monthly August 2005, p. 2). In Phase III studies, Trexima demonstrated statistical superiority for the primary endpoint of sustained pain-free response over the individual drugs sumatriptan and naproxen...
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