Thursday, October 21, 2010
Migraine sufferers who haven’t found relief in prescription or over-the-counter medications can now seek help from the same drug that erases crows’ feet and forehead wrinkles. The U.S. Food and Drug Administration last week approved the use of Botox®, delivered through a couple of dozen needle pricks around the head and neck, to prevent chronic migraines—which for approval purposes means severe headaches of four hours or more at least 15 days a month. Great Britain approved Botox® for the same purpose in July.
But getting needled is neither risk-free nor the solution for every migraine sufferer.
The FDA based its decision on two 24-week trials involving a total of 1,384 adults in North America and Europe. Both trials were funded by drug maker Allergan, which last month agreed to pay $600 million for illegally promoting Botox® for headaches, which, at the time, were not an FDA approved use. By the end of the first trial, those who received Botox® experienced 7.8 fewer migraine days during the 24 weeks than they experienced during the 24 weeks leading up to the trial compared with 6.4 fewer days for those injected with a placebo of plain salt water. The Botox® group in the second trial had 9.2 fewer migraine days while the placebo group had 6.9 fewer days. Allergan published its results last March in the journal Cephalalgia, the medical term for headache. The differences are significant by clinical trial standards, but “not huge,” says Avi Ashkenazi, a Doylestown, Pa., neurologist who has published papers on the subject, including one in Current Neurology and Neuroscience Reports.