It began as an odd observation among plastic surgery patients, and ended up as an FDA approved drug — on Friday, the agency green-lighted the use of Botox, a popular wrinkle-reducing procedure, to control migraines.
Headache experts have been using Botox for some of their migraine patients for more than a decade now, says Dr. Merle Diamond, director of the Diamond Headache Clinic in Chicago, ever since some patients receiving the injections in their foreheads reported a drop in the number of their migraine episodes. But such use was off-label, meaning there was no solid scientific evidence supporting the practice, nor trial data on its safety. And, because it was not approved for treating migraine, patients who agreed to try it paid several thousands of dollars out of pocket for each treatment. (More on Time.com: Need Health Insurance? Click Here).
But Botox’s manufacturer, Allergan, launched two large studies of migraine patients to satisfy strict FDA criteria for adding a new use for the botulinum toxin injections — Botox is currently only approved for cosmetic purposes to relax deep furrows in the face, or to relieve muscle disorders or excessive sweating. But researchers have been studying ways that Botox may relieve everything from depression to other disorders by relaxing muscles.
In the trials involving more than 1,300 headache patients, those with chronic migraines had the best response to the treatment, which involves receiving 31 injections in the head and neck. After six months, the treated patients reported 7.8 fewer headache days on average each month compared to 6.4 fewer days in the placebo group. (More on Time.com: Top 10 Product Recalls).
“We all knew that in a certain population of patients, [Botox] seemed to be an effective drug for migraine,” says Diamond. “The reality is that this works for the very tough patient with chronic migraines that are in general not responsive to traditional prevention approaches. And these patients are frustrated because they keep putting pills in their mouth and are still having more than 15 days of headaches a month. They’re having the side effects of those medications, and are still having frequent migraines.”
Common treatments for migraine include antidepressants, blood-pressure medications and medications that target the brain chemical serotonin, which is involved in regulating mood, satiety and satisfaction. Each of these has side effects, and they don’t all work as effectively in migraine patients. (More on Time.com: Botox Manufacturer: $600 Million Poorer, But closer to New Uses).
Diamond stresses that Botox is no magic bullet either, and the biggest question about the drug, despite its approval, is which migraine patients will respond to the Botox injections. “I can’t predict which chronic migraine patient will respond to Botox,” she says. “Does it work for everybody? No. And we certainly don’t know about its safety for pregnant women. But we are excited for our patients and think it gives them more options.” And, she notes, with the FDA approval more patients may be able to take advantage of Botox’s potential benefits if insurance companies start to cover the treatments.
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