Botox has been approved in the U.K. as a tool for preventing chronic migraine headaches. 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, according to Allergan’s press release.
The clinical trial involved almost 1,400 adults who had a history of migraines. Participants experienced 15 or more headache days of which at least half were migraine or probable migraine during the 28-day baseline period. After the baseline period, patients were randomized to receive either Botox injections or placebo.
By week 24 following treatment, those 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.
“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 Lee Tomkins, director of Migraine Action, a charity that provides information and support to those who suffer from migraines and their families throughout the U.K. and overseas.
The U.S. Food and Drug Administration may 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., Botox can be used to treat eye muscle spasms and wrinkles, and there are also many off-label uses for Botox, such as to relax muscles in stroke patients and to treat excessive sweating.
According to statistics from the American Society of Plastic Surgeons, Botox was the number one minimally-invasive cosmetic procedure in 2009 in the United States.