Botox wins FDA nod for use in treating migraines

November 2, 2010

The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA, Allergan) for treatment of migraine headaches, the Associated Press reports.

Washington - The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA, Allergan) for treatment of migraine headaches, the Associated Press reports.

The FDA approved the drug for patients who experience 15 or more days of migraine headaches per month. The agency’s approval was based on two company studies of more than 1,300 patients who received either a Botox or a dummy injection. Patients who received Botox reported having fewer “headache days” than those given the placebo.

Best known for its wrinkle-smoothing capabilities, Botox was approved earlier this year to treat spasms of the elbows, wrists and fingers, and is commonly used off-label to treat broader movement disorders, such as cerebral palsy.

More than 3 million people in the United States experience chronic migraine headaches, according to Allergan.