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Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Date:4/15/2008

Clinical studies show Treximet provided significantly more patients

migraine pain relief compared to sumatriptan 85 mg

LONDON, April 15 /PRNewswire-FirstCall/ -- GlaxoSmithKline (LSE: GSK) (NYSE: GSK) and POZEN Inc. (Nasdaq: POZN) 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 Trexime
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SOURCE GlaxoSmithKline
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