15 Sep FDA Reviewing Botox® for Chronic Migraine
Botox (botulinum toxin type A) took one step closer to being approved for use in the United States. as a preventive treatment for chronic migraines. Botox manufacturer Allergan expressed confidence that a recent request for information from the US Food and Drug Administration (FDA) is a positive sign.
Specifically, the FDA asked for an updated Risk Evaluation and Mitigation Strategy on how to safely market Botox for potential anti-migraine use. Allergan has supplied the information, which includes a plan for training healthcare professionals on the use of Botox for chronic migraine. The FDA is taking three months to review the information and expects to make a decision in October.
According to Allergan, the new developments suggest that no more trials will be required to gain approval. Botox was approved for the prevention of chronic migraine in the United Kingdom in July. It was the first license worldwide of Botox for the treatment of migraine.
Trials of Botox for the prevention of migraine have had varied results. In one trial, Botox didn’t succeed in reducing the number of headache attacks compared to placebo, but did reduce the number of headache days each month by 7.8 compared to 6.4 fewer days in those who received the placebo. In another study, Botox patients had nine fewer headache days compared to 6.7 fewer in the placebo group.