FDA Approves New Class Of Migraine Drug

Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 May 2008 - 7:00 PDT

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If you're one of the nearly 30 million Americans* who suffers from migraine headaches, you now have a new way to fight them. This month, a new drug is expected to land in pharmacies that combines two existing migraine drugs.

Most days, Richard Higgins is very active. If he's not training for triathlons, he's doing karate with his kids. The only thing that seems to slow him down is his migraine headaches. The only thing Richard takes for them is over-the-counter pills, although he says they rarely work.

"Even when I do take the medicine, I can still feel the pain. And I still have trouble concentrating, still have the tunnel vision, still have a lot of the symptoms," says Higgins. Richard knows there's a stronger class of drugs available, but like many other migraine sufferers, he's hesitant to use them.

"It's a sedative. Most patients can get addicted to this medication. Patients have cognitive and thinking problems," says Yousef Mohammad, MD, with Ohio State University Medical Center.

Now, a new drug on the market may offer relief without addiction. It's called treximet. Dr. Mohammad is helping to study it. He says the drug works by combining two existing drugs that control two different aspects of migraine headaches. First, it prevents blood vessels in the head from narrowing. Second, it blocks the brain from releasing chemicals that signal pain.** Dr. Mohammad says it could be an important new option for the millions who can't find migraine relief.

"There are treatments for migraine headaches, however only half of migraine patients respond to them. So there is a need for an additional treatment for these patients," says Mohammad.

Even though treximet just won FDA approval, studies continue. Doctors want to better determine who it will help and why. They also want to make certain that side effects, especially those related to the heart, are manageable. Doctors continue to search for migraine sufferers to participate in the latest study.

Of those who get migraines, up to 80% have a family history.* Migraines affect women about 3 times more often than men.*

*Migraine, National Headache Foundation, retrieved April 2008 from http://www.headaches.org

**Treximet Phase 3 Pivotal Trials, Pozen, found at http://www.pozen.com/product/trexima.asp

Ohio State University

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