FDA approves Treximet for acute migraine treatment

LONDON GlaxoSmithKline and Pozen announced this week that the Food and Drug Administration has approved Treximet for the acute treatment of migraine attacks with or without aura in adults.

Treximet is 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 85 mg sumatriptan, the active ingredient in Imitrex, and 500 mg naproxen sodium, which is most commonly marketed as painkiller Aleve.

“Migraine patients want their medicine to work early, and to continue to provide relief,” said one of the trial investigators, Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University. “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.”

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

Findings from these studies showed that Treximet was more effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours than either of its component medications alone. In addition, Treximet more effectively relieved migraine associated symptoms—nausea and sensitivity to light and sound—compared to a placebo.

Migraine headaches continue to be a significant problem for the estimated 29.5 million Americans, nearly half of which are undiagnosed, according to GSK. Recent research suggests that migraine involves a complex chain of events that are both neurovascular and inflammatory. The sumatriptan in Treximet mediates vasoconstriction, which correlates with the relief of migraine headache. The naproxen, meanwhile, acts as an anti-inflammatory agent. The combination, therefore, of sumatriptan and naproxen sodium contributes to the relief of migraine through pharmacologically different mechanisms of action, GSK stated.