FDA approves Treximet for migraine treatment

FDA approves Treximet for migraine treatment
FDA approves Treximet for migraine treatment

Treximet (sumatriptan and naproxen sodium tablets, from GlaxoSmithKline and POZEN) has been approved by the FDA for the acute treatment of migraine attacks with or without aura. Treximet targets multiple mechanisms of migraine by combining a triptan and an NSAID in a single tablet. This approval is supported by double-blind trials involving >2900 patients that showed Treximet provided more patients with migraine relief at 2 and 4 hours compared to sumatriptan 85mg, naproxen sodium 500mg or placebo alone. Treximet was also more effective at maintaining pain relief from 2 to 24 hours.

Treximet is expected to be available in pharmacies by mid-May 2008.

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