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news.Allergan has received MHRA license for Botox (botulinum toxin type A) in the UK for the prophylaxis of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).
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Allergan claimed that the current license is the first license worldwide of Botox for this indication, and is also the first prophylactic (preventative) treatment to receive a specific license for patients with chronic migraine.
The PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) trail evaluated the safety profile and efficacy of Botox as a prophylactic (preventative) headache treatment in chronic migraine patients.
In the trail, the patients treated with Botox experienced fewer headache days compared to those patients treated with placebo.
Allergan said that the patients treated with Botox had major improvement from baseline in their quality of life scores (MSQ scores) and in the amount of headache related disability (HIT6 scores) compared with those on placebo, indicating significant improvement in patients functioning, vitality, psychological distress, and overall quality of life
Scott Whitcup, executive vice president of R&D and chief scientific officer of Allergan, said: “The authorisation of Botox marks an evolution in medical care for the prevention of headache in adults with chronic migraine. It is also a significant milestone in the history of Botox and Allergan is proud to advance novel treatments in the field of neurology through our neurosciences research programme.”
Peter Goadsby, professor of UCL- Institute of Neurology, London and University of California, San Francisco, said: “Botox treatment has been shown to reduce the frequency of headache/migraine, which can bring important benefits for patients.”