POZEN SUBMITS NDA FOR MIGRAINE MEDICATION

Pozen has announced the submission of a new drug application (NDA) to the FDA for the marketing approval of Trexima, the proposed brand name for the combination of sumatriptan succinate and naproxen sodium, in a single tablet for the acute treatment of migraine.

Migraine affects more than 28 million people in the U.S. alone, of which roughly three out of four migraine sufferers are women. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches lasting four to 72 hours (untreated) and with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting and sensitivity to light and sound. Migraine can be disabling and sufferers may miss days of work, lose time with family and friends, and be unable to pursue basic daily activities.