GSK's Treximet receives FDA approval

20 April 2008

UK drug major GlaxoSmithKline and US company Pozen's co-developed long-awaited migraine drug, Treximet, has finally received US Food and Drug Administration approval. The drug, a combination of Glaxo's Imitrex triptan and an anti-inflammatory, is indicated for the acute treatment of migraine attacks with or without aura in adults. The FDA had asked the companies for more data on Treximet twice since the the product was first submitted in 2005. Two clinical studies have since confirmed the drug provided a significantly greater percentage of patients experiencing relief of migraine symptoms after two hours than sumatriptan 85mg or naproxen sodium 500mg.

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