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Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Migraine-Free,Response Across Multiple Attacks

Nearly Twice as Many Patients Taking Trexima were Migraine Free Compared to Placebo

CHICAGO, June 08, 2007 /PRNewswire/ -- New data from two large trials show that Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours across multiple attacks with just one tablet. The findings will be presented tomorrow at the 49th Annual Scientific Meeting of the American Headache Society.

In addition to head pain, migraine attacks often include nausea, vomiting and sensitivity to light or sound, making it difficult for sufferers to participate in daily activities. Most migraine studies focus on pain relief or pain-freedom, which only assesses head pain. This is one of the few studies to measure migraine-free response across multiple attacks, which is significant because it means that the associated symptoms of migraine, as well as the head pain, are gone.

"I believe this key endpoint will have more meaning to patients, as it measures when the whole migraine is gone rather than just the head pain," said Dr. Paul Winner, lead author and director of the Palm Beach Headache Center. "In these studies we found Trexima consistently eliminated migraine symptoms in more patients without the need for rescue medication."

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. Migraine-free response is defined as freedom from migraine pain, nausea, vomiting, sensitivity to light and sound, and without the use of rescue medication at or before the time points specified. Subjects were randomized to one of five
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