GlaxoSmithKline and Pozen reported that the FDA approved Treximet (sumatriptan/naproxen) for the acute treatment of migraines with or without aura in adults. The drugmakers stated that the compound is the first migraine drug "designed to target multiple mechanisms of migraine by combining a triptan...and an anti-inflammatory" in a single tablet.
The treatment was first submitted for approval in 2005, but the drugmakers received two approvable letters from the FDA requesting additional safety data on the compound. The companies said they expect to launch Treximet in the country in mid-May, and Vontobel analyst Odile Rundquist forecast that peak annual sales of the compound could reach about 940 million pounds ($1.85 billion).
The sumatriptan component of Treximet is the active ingredient in GlaxoSmithKline's Imitrex, which may face generic pressure this year, and Rundquist noted that "Treximet is important for the life-cycle management" of the older migraine drug. Shares of Pozen gained as much as 39 percent on the news.
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