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GSK, Pozen Gain FDA Approval for Migraine Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline and Pozen, Inc. received FDA approval of Treximet for the treatment of migraine attacks in adults. Treximet is the first migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of GSK’s migraine-specific medicines, and an anti-inflammatory pain reliever in a single tablet. The product is expected to be available in U.S. pharmacies by mid-May.
   
Treximet contains 85 mg sumatriptan, formulated with RT Technology, and 500 mg naproxen sodium. Sumatriptan is the active ingredient in GSK’s Imitrex Tablets, available in 25 mg, 50 mg and 100 mg strengths. The approval of Treximet was based on data from two double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers. In the trials, Treximet showed a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. Treximet also provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components. Treximet was generally well-tolerated in these studies.

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