Wednesday, April 16, 2008

Sumatriptan and Naproxen Sodium combination Tablets Approved by FDA for Acute Treatment of Migraine

GlaxoSmithKline and POZEN Inc. announced today that the FDA has approved Treximet (Sumatriptan and Naproxen Sodium) tablet 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. 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 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.

About RT technology....

GSK’s RT Technology, which is currently used in currently marketed Imitrex® tablets, is designed to enhance the dispersion and dissolution of oral tablets in the stomach, even in the presence of gastric stasis. Gastric motility is commonly slowed during a migraine. Imitrex tablets formulated with RT Technology™ quickly disintegrate and rapidly release into the bloodstream.

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