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Treximet(TM) (sumatriptan and naproxen sodium) Tablets Shown to be Effective in Patients Who Previously Had Poor Response to, or Did Not Tolerate, Migraine Treatment with a Short-Acting Triptan
Friday, June 27, 2008 11:16 AM
Symbols: GSK
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BOSTON, June 27 /PRNewswire-FirstCall/ -- New data offer hope for migraine sufferers who report that they have poor response or are intolerant to their migraine therapy. Two studies of migraineurs who reported that they had poor response to, or did not tolerate, short-acting triptans, showed that treatment with Treximet provided sustained pain-free results at two through 24 hours and was generally well-tolerated. These studies were presented today at the 50th Annual Scientific Meeting of the American Headache Society in Boston.

'This information is important to people who have tried and have not yet found relief from short-acting triptans,' stated Ninan Mathew, M.D., director of the Houston Headache Clinic and lead author of the study. 'Patients often need to try several medications before finding a therapy that is effective. Migraine sufferers should not be discouraged if the first treatment they try doesn't provide the relief they need, but rather should speak with their doctor and re-evaluate their migraine treatment.'

These data also underscore the benefits of Treximet, a prescription treatment that addresses both the early and late stages of a migraine. Treximet, the only migraine treatment designed to target multiple mechanisms of migraine by combining a triptan and an anti-inflammatory pain reliever in a single tablet, was approved by FDA in April of this year.

About the Studies

The data are from two identical randomized multi-center, double-blind, placebo-controlled crossover trials that evaluated 283 men and women who typically had a history of four to five migraines each month. Subjects in these studies had, on average, a 22 to 24-year history of migraine without aura and reported that they had discontinued treatment with a short-acting triptan due to poor response or intolerance within the past year. Subjects were randomized to receive Treximet or placebo and were instructed to treat within an hour of onset of the migraine while the headache pain was still mild.

In both studies:

-- Treximet was superior to placebo in producing sustained pain-free results from two through 24 hours (26 percent vs. 8 percent in Study 1; and 31 percent vs.



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