Pozen Inc. has submitted a New Drug Application (NDA) to the US FDA for the marketing approval of Trexima, the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology, and naproxen sodium, in a single tablet for the acute treatment of migraine.
Dr. Marshall Reese, executive vice president, product development stated, "We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline (GSK) and Pozen."
Upon the FDA's acceptance for filing of the Trexima NDA, a $20 million milestone payment from GSK is payable to Pozen.
Migraine affects more than 28 million people in the Unites States alone, of which roughly three out of four migraine sufferers are women.