New Combo Migraine Drug in the Works

Drug, Called Trexima, Combines 2 Other Migraine Drugs

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

April 3, 2007 -- A new migraine drug may bring more migraine relief than two other migraine drugs, a new study shows.

The new drug, called Trexima, is a blend of the migraine drug Imitrex and the pain reliever naproxen sodium, which is found in drugs including Aleve, Anaprox, and Naprosyn.

Imitrex and naproxen sodium work differently. Trexima combines those tactics to ease migraines in two different ways.

Trexima isn't on the market yet, but it has been submitted for FDA review.

Results of two Trexima trials appear in the April 4 edition of The Journal of the American Medical Association. Together, the trials included 2,956 adult migraine patients.

The patients were about 40 years old on average. Most were white women.

The researchers included Jan Lewis Brandes, MD, of Tennessee's Nashville Neuroscience Group. They split the patients into four groups.

The first group got Trexima pills. The second group got Imitrex. A third group got naproxen sodium. The fourth group got an inactive pill (placebo).

Patients were told to take their assigned pill when migraine symptoms became moderate or severe during the following six weeks. They noted migraine symptoms and migraine pain in the 24 hours after taking their pill.

Trexima "resulted in superior clinical benefits" when compared with Imitrex, naproxen sodium, or placebo, note Brandes and colleagues.

In both trials, more patients taking Trexima reported migraine relief two hours after taking their assigned pill and sustained headache relief more than 24 hours after taking the pill.

Fewer patients taking Trexima reported sensitivity to light and sound (two common migraine symptoms) two hours after taking their assigned pill, the study shows.

Side effects were relatively rare, but they were twice as common in the Trexima group as in the placebo group.

Trexima had an "acceptable and well-tolerated" side effect profile, write the researchers. A similar proportion of patients taking Trexima and Imitrex reported side effects.

The researchers didn't test Imitrex and naproxen sodium taken at the same time in separate pills. They write that the combination pill has "obvious advantages" for patients who have trouble taking two pills.

The study was funded by GlaxoSmithKline, which makes Imitrex, and Pozen Inc., which makes Trexima. GlaxoSmithKline is a WebMD sponsor.

A Pozen news release says the FDA may decide on Trexima by Aug. 1, 2007. If so, the drug "could be available to patients in the second half of 2007," states Pozen.

SOURCES: Brandes, J. The Journal of the American Medical Association, April 4, 2007; vol 297: pp 1443-1454. News release, JAMA/Archives. News release, Pozen.

© 2007 WebMD Inc. All rights reserved.

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