Botox for Migraines Approved in U.K., U.S. May be Next
The U.K.’s drug regulator became the first in the world to approve Botox as a tool for preventing chronic migraine headaches, Allergan announced last week. Best known as a wrinkle treatment, it can now be used on migraine patients in the U.K. who have headaches at least 15 days a month, including migraines on 8 days.
Allergan’s clinical trial involved 1,384 adults who had a history of migraines and experienced 15 or more headache days of which at least 50 percent were migraine or probable migraine during the 28-day period. At the end of the baseline period, patients were randomized to receive either Botox injections or placebo.
By week 24 following treatment, patients who received Botox averaged 8.2 fewer migraine days, which was significantly greater than the change from baseline observed in placebo treated patients of 6.2 days.
Lee Tomkins, director of Migraine Action, stressed it was not a “cure” but it offered hope for those who suffer the most frequent migraines. Migraine symptoms may include severe headache; visual disturbances such as spots or flashing lights; sensitivity to light, noise, or smells; and nausea and vomiting.
“We have been following these studies really closely and the evidence is really pretty solid. These people spend half their lives in pain. Even if they get half the attacks, it can really improve their quality of life,” said Tomkins.
In the United States, the Food and Drug Administration is likely to decide this month whether the product can be sold for migraines, Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, said in May. In the U.S., in addition to treating wrinkles Botox can be used to treat eye muscle spasms and muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity.
Botox was the number one minimally-invasive cosmetic procedure in 2009 according to the American Society of Plastic Surgeons’ most recent statistics, which showed that the procedure was performed 4.8 million times in the U.S. last year for cosmetic purposes. Dr. Stacy performs the procedure in her Bellevue, Washington office.
Tags: botox, statistics
