FDA OKs New Migraine Drug Treximet

April 16, 2008 -- The FDA has approved a new migraine drug called Treximet for the acute treatment of migraine attacks, with or without aura, in adults.

Treximet is a combination of sumatriptan (the active ingredient in the migraine drug Imitrex) and the anti-inflammatory painkiller naproxen sodium (the active ingredient in Aleve and Naprosyn).

Treximet is expected to be available in U.S. pharmacies by mid-May, according to a joint news release from GlaxoSmithKline and Pozen, the drug companies marketing Treximet.

GlaxoSmithKline and Pozen say that in clinical trials, Treximet worked better than a placebo or either of its two active ingredients alone, with relief lasting from two to 24 hours. Treximet also trumped a placebo at reducing symptoms associated with migraines, such as nausea and sensitivity to light and sound.

In clinical trials, Treximet was generally well tolerated, according to the drug companies; the most common adverse events reported within 24 hours of taking Treximet were dizziness; nausea; sleepiness; chest discomfort; pain in the neck, throat, and jaw; tightness and pressure; numbness or tingling; and dry mouth.

WebMD reported on the drug last year, before its name change from Trexima to Treximet.

GlaxoSmithKline and Pozen note that Treximet may cause an increased risk of serious cardiovascular clotting events, such as heart attack and stroke, and shouldn't be given to patients with heart disease.

And because naproxen sodium is a nonsteroidal anti-inflammatory drug, Treximet carries a risk of serious gastrointestinal problems, including bleeding and ulcers.