Botox Gets U.K. License as Migraine Treatment

The U.K.’s drug regulator became the first in the world to approve BOTOX® as a treatment for preventing chronic migraine headaches, Allergan announced last week. While it is 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.

The U.K. approval could shortly precede a decision on BOTOX® as a migraine treatment from the U.S. Food and Drug Administration, according to the Wall Street Journal.

The clinical trial had 1,384 adult participants who had a history of migraines and who experienced 15 or more headache days of which at least 50 percent were migraine or probable migraine during the trial’s 28-day baseline period. After the baseline, patients were randomized to receive either BOTOX® injections or placebo.

Patients who received BOTOX® 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 the U.K.’s Migraine Action, stressed it was not a “cure” but said it offered hope for those who suffer the most frequent migraines. “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 2009, BOTOX® was the number one minimally-invasive cosmetic procedure, according to the American Society of Plastic Surgeons’ most recent statistics. BOTOX® is also the most popular non-surgical treatment at Dr. Branman’s Little Rock office.