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Trexima (Sumatriptan/Naproxen Sodium) Superior Efficacy Data,Published in JAMA

Trexima provided superior sustained pain-free results compared to sumatriptan

RESEARCH TRIANGLE PARK and CHAPEL HILL, N.C., April 03, 2007 /PRNewswire-FirstCall/ -- -- Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Trexima(TM) provided superior headache relief at two hours and four hours compared to placebo, and two through 24-hour sustained pain-free results versus sumatriptan or naproxen monotherapy. The results were published today in the Journal of the American Medical Association (JAMA).

"Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways," said lead author Jan Lewis Brandes, M.D., assistant clinical professor at Vanderbilt University School of Medicine and director of the Nashville Neuroscience Group. "These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components."

Trexima is the proposed brand name for a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg, for the acute treatment of migraine. These studies were the pivotal efficacy studies included in the New Drug Application currently under review by the FDA.

Trexima: Both Early and Sustained Relief

To help evaluate the efficacy and safety of Trexima, two randomized, double-blind, parallel-group, placebo-controlled single-attack studies were conducted in 118 sites in the United States. A total of 3,413 patients were randomized to receive a single Trexima tablet, a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM), a single tablet containing naproxen sodium 500 mg, or placebo. If patients did
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