FDA Approves Use of Botox to Treat Migraines

Posted on October 15, 2010

BotoxThe U.S. Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. The FDA says Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound.

Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said, "Chronic migraine is one of the most disabling forms of headache. Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available."

When treating for chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms.

Allergan said in a statement that its Botox drug was approved by the FDA based on data collected in its PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program. The program was designed to evaluate the safety and efficacy of Botox as a preventive treatment of headaches in adults with Chronic Migraine.

CNN has more details on the use of Botox to treat migraines here.