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USFDA approves Treximet to treat acute migraine PDF Print E-mail
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Written by Administrator   
Saturday, 19 April 2008

UK drug giant GlaxoSmithKline and US-based pharma company Pozen have received  US FDA approval for Treximet to treat acute migraine attacks with or without aura in adults.

Treximet is designed to target multiple mechanisms of migraine by combining a triptan – a class of migraine-specific medicines by GSK – and an anti-inflammatory pain reliever in a single tablet.

The approval of Treximet was based on data from two identical double blind, randomized, placebo-controlled, parallel group and multicenter studies of more than 2,900 migraine sufferers.

Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies Treximet was effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours. In addition, Treximet effectively relieved migraine associated symptoms – nausea and sensitivity to light and sound – compared to placebo.

 
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