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Botox® Gets the Green Light in the UK

Botox (botulinum toxin type A) has been approved for the prevention of chronic migraine in the United Kingdom. This is the first license worldwide of Botox for the treatment of migraine.

The approval was based, in part, on the PREEMPT trial (Phase III REsearch Evaluating Migraine Prophylaxis Therapy), which enrolled 1,384 adults with chronic migraines (defined as 15 or more headache days per month). Most of the enrollees had tried at least one other preventive medication and/or were overusing acute headache medications. They were given either placebo or Botox injections in specific head and neck muscles over the course of 56 weeks. Those receiving the Botox injections averaged fewer migraine days than those on placebo. By week 56, nearly 70% of Botox patients had a 50% or greater decrease in the number of migraine days. They also showed significant improvement in quality-of-life scores.

Trials of Botox for the prevention of migraine done in the U.S. have had varied results and the U.S. Food and Drug Administration has not approved Botox for the treatment of headaches.

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