A few months ago a blog post explained Botox’s potential to work as a migraine treatment, and now the U.K.’s drug regulator has become the first in the world to approve Botox for the use of preventing chronic migraine headaches, Allergan announced last week. While best known as a cosmetic wrinkle treatment, Botox 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 PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) involved almost 1,400 adults with a history of migraines and who experienced 15 or more headache days of which at least 50 percent were migraine or probable migraine during a baseline 28-day period. At the end of the period, patients were randomized to receive either Botox injections or placebo.
Patients in the Botox group averaged 8.2 fewer migraine days by week 24 following treatment, which was significantly greater than the change from baseline observed in placebo treated patients of 6.2 days.
Lee Tomkins, director of Migraine Action, said, “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.” Migraine Action says one in seven people in the UK suffer from migraine, affecting twice as many women as men.
The U.S.’s 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.
Botox is still the most popular minimally-invasive cosmetic procedure in the U.S., 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. in 2009 for cosmetic purposes.