Botox still far from a cure-all for migraines

November 8, 2010 12:00:00 AM PST
The future of the popular cosmetic drug Botox is receiving fresh attention after its recent approval for use in treating migraine headaches. It marks a turning point for manufacturer Allergan, which recently paid a $600 million settlement for marketing Botox for off-label or unapproved uses. But even with the FDA's OK, some headache experts are cautioning that Botox is still far from a cure-all for migraines.

Painter Hilary Zim, 70, is getting Botox injections, but it's not to smooth out wrinkles.

"It takes a few hours and then the pain subsides," says Zim.

Zim has been a patient in a widely-publicized clinical trial, testing the use of Botox to treat chronic migraine headaches.

"In my case, they have been so severe that you certainly can't have a career of any kind and spend most of your time in bed," says Zim.

Headache specialist Jerome Goldstein believes the recent approval of the drug by the FDA marks a legitimate advance for a subset of migraine patients.

"This 10 to 20 percent of all the migraine sufferers, but of those people, there will be a smaller percentage who will respond to the Botox therapy," says headache researcher Jerome Goldstein, M.D.

Allergan, the company which manufactures Botox, has been working for years to get it approved for migraine treatment. And now that it has FDA approval, some are cautioning there are limitations.

One reason is the placebo effect. In the Allergen study, patients who received an injection with just saline had about six to seven fewer days with headaches per month. Patients who received Botox fared only slightly better, with roughly eight to 10 fewer headache days. That improvement was only documented in patients with the less common form of chronic migraine.

"Most of the people that we see here in our clinical research center and headache clinic have intermittent migraine headaches and they have one, two, four, maybe even six a month that are very, very successfully treated with stripped down medications and I wouldn't anticipate that these people would need that type of therapy," says Goldstein.

But while fewer patients are diagnosed with these chronic daily headaches, Dr. Goldstein points out that condition has proven more difficult to treat with current medications. For Zim, this new option is making a difference.

"I've been able to resume now my work after many years and it's the best I've felt in a long time," says Zim.

Clinical trials are underway using Botox to treat cerebral palsy. Allergan is hoping for FDA approval for that use as well.

Written and produced Tim Didion


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