Pozen Inc. has announced the amended response to a previous FDA approvable letter for Trexima has been accepted for review by the US Food and Drug Administration (FDA).

Trexima is 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. The FDA has also notified Pozen that it expects a class II review (six months), which could result in a new decision date of August 1, 2007. Pending FDA approval, the product could be available to patients in the second half of 2007.

Migraine affects more than 28 million people in the Unites States 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 4 to 72 hours (untreated) and with symptoms including moderate to severe headache pain, which is typically throbbing, unilateral, and aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound. Migraine can be disabling and sufferers may miss work, lose time with family and friends, and be unable to pursue basic daily activities.

Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.