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Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Efficacy Across,Multiple Migraine Attacks

Study Results Show Individuals Reported Consistent Pain-Free Results From Attack to Attack

BOSTON, May 02, 2007 /PRNewswire/ -- Patients who suffer from migraines frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. New data from more than 1,100 patients show that the investigational migraine therapy Trexima, when taken early, produced pain-free results at two and four hours, as well as a sustained pain- free response 2-24 hours, across individual patients' multiple migraine attacks, demonstrating the consistency in efficacy that patients desire. Furthermore, nearly one third of all patients were pain free at two hours. These findings were presented today at the 59th Annual Meeting of the American Academy of Neurology.

"The anticipation of the next attack can be quite stressful for patients," said Richard Lipton, MD, Professor of Neurology, Epidemiology and Social Medicine, Albert Einstein College of Medicine in New York. "Patients want a treatment that works quickly and provides consistent relief for each attack. These data are significant because they show that Trexima produced consistent pain-free results across multiple attacks in the same patient."

Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM) and naproxen sodium 500 mg, is currently under review by the FDA for the acute treatment of migraines in adults.

About the Studies

The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. The study incorporated an early intervention model in which patients were instructed to treat while migraine pain was mild and within one hour of onset. Patients were randomized to one of five groups and instructed to treat four migraine attacks. Most patients (80 percent) treated three of four attacks with Trexima and
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