FDA approves onabotulinumtoxinA to prevent chronic migraine

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine. To prevent chronic migraine, onabotulinumtoxinA is injected about every 12 weeks in multiple sites around the head and neck to try to dull future headache symptoms.

Irvine, Calif.-based Allergan provided FDA substantial evidence of safety and effectiveness to support the new indication of prophylaxis for headaches in patients with chronic migraine, an agency spokesperson told Drug Topics.

According to FDA, onabotulinumtoxinA has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month or for other forms of headache.