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GSK/Pozen Trexima update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pozen plans to submit an NDA in the third quarter for its migraine combination therapy Trexima (sumatriptan/naproxen) following a pre-NDA meeting with FDA. The firm also announced that Trexima showed statistically significant results for all primary endpoints in a second pivotal trial. Based on discussion at the pre-NDA meeting, Pozen "believes that no additional preclinical or clinical trials are necessary for submission," the firm says April 21. In the pivotal trial, Trexima showed superiority over its individual components with respect to pain-free response and pain relief. At the moment, Trexima appears to be Pozen's most promising product. The firm's other migraine agents, MT-100 and MT-300, are both "not approvable" at FDA. The agency recently postponed an MT-100 advisory committee...

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