Pozen Trexima NDA filing relieves MT 100 headache
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pozen's submission of an NDA for migraine treatment Trexima (sumatriptan/naproxen) Aug. 8, anticipated to receive a standard review, sets a user fee goal date of June 8, 2006. The submission follows a negative review of Pozen's MT 100 (naproxen/metoclopramide) combination migraine agent by FDA's Peripheral & Central Nervous System Drugs Advisory Committee Aug. 4. Pozen discontinued U.S. development of MT 100 the day after the meeting. GSK will market Trexima upon approval under a June 2003 agreement. In Phase III studies, Trexima demonstrated statistical superiority for the primary endpoint of sustained pain-free response over the individual drugs sumatriptan and naproxen. In addition, Phase III studies showed Trexima was statistically superior to its individual components in two-hour pain response endpoints, the company said...