Pozen, GSK submit Trexima response

POZN and partner GlaxoSmithKline (LSE:GSK; GSK) submitted a response to an August approvable letter for Trexima sumatriptan/naproxen to treat acute migraine. The submission included results of three in vitro studies that POZN said "provide clarifying information" about a previous study in which genotoxicity was seen for the combination of naproxen and sumatriptan but not for either component alone. POZN plans to begin a short-term clinical trial this quarter to evaluate the genotoxic potential of Trexima in case FDA requires the data. Data are expected in 1Q08. ...