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Migraine Medication Treximet Approved by FDA

LONDON, April 15 /PRNewswire-FirstCall/ -- GlaxoSmithKline and POZEN Inc. announced today that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.

Treximet contains 85 mg sumatriptan, formulated with RT Technology(TM), and 500 mg naproxen sodium. Sumatriptan is the active ingredient in Imitrex(R) Tablets, available in 25 mg, 50 mg and 100 mg strengths. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.

"Migraine patients want their medicine to work early, and to continue to provide relief," said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and an investigator who participated in clinical trials. "The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients." Further, Silberstein said, significantly fewer patients on Treximet required the use of a rescue medication to treat their migraine attack than those taking sumatriptan 85 mg.

Treximet is well studied, with more than 3,700 migraine sufferers treating nearly 30,000 migraine attacks in clinical studies. The product is expected to be available in U.S. pharmacies by mid-May.

Clinical Trials Demonstrated Superior Efficacy to Individual Components

The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.

Findings from these pivotal studies demonstrated that Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies Treximet was effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours. In addition, Treximet effectively relieved migraine associated symptoms -- nausea and sensitivity to light and sound -- compared to placebo.

Treximet was generally well-tolerated in these pivotal studies. The most common treatment-related adverse events reported within 24 hours of taking Treximet were dizziness; nausea; somnolence; chest discomfort and chest pain; neck, throat and jaw pain, tightness and pressure; numbness/tingling; upset stomach; and dry mouth.

Treximet was also studied in a one-year open-label tolerability and safety study of 565 patients who treated nearly 24,500 migraine attacks with the active drug. Patients completing the one-year study treated an average of five migraine attacks per month with Treximet.

Migraines Impact Millions of Americans

Migraine headaches continue to be a significant problem for the estimated 29.5 million Americans, nearly half of which are undiagnosed. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches which, if untreated, typically last four to 72 hours, 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.

In the past, many clinicians believed that migraine was a vascular condition, induced by blood vessel dilation alone. Today, new insight suggests that migraine is much more complex, involving a chain of events that are both neurovascular and inflammatory. Treximet contains sumatriptan that mediates vasoconstriction, which correlates with the relief of migraine headache. It also contains naproxen, an anti-inflammatory agent. Therefore, sumatriptan and naproxen sodium contribute to the relief of migraine through pharmacologically different mechanisms of action.

Source: GlaxoSmithKline and Pozen

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