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 releasefromGlaxoSmithKline 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.

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