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GSK and Pozen announce approval of migraine drug

GlaxoSmithKline and Pozen have reported that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults.

Treximet is said to be the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.

Treximet contains 85mg sumatriptan, formulated with RT Technology, and 500mg naproxen sodium. In clinical trials, Treximet provided a significantly greater percentage of migraine pain relief at two hours compared to sumatriptan 85mg or naproxen sodium 500mg alone. The product is expected to be available in US pharmacies by mid-May of 2008.

Stephen Silberstein, an investigator who participated in clinical trials, said: “The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients.”