UK regulators became the first to approve Allergan's Botox for chronic migraine on July 9, as the company's strategy of finding additional indications for the neurotoxin continued to bear fruit.

Botox (botulinum toxin type A) is the first prophylactic medicine to receive a specific license for patients with chronic migraine, claims Allergan. However, it is not for the fainthearted.

Up to 39 injections of Botox are administered into seven specific muscle areas around the head and neck, every 12 weeks. This uses around 155 to 195 units of Botox for each set of 30-40 injections, at a cost to the National Health Service of around £276 per patient.

Patients must have headaches for at least 15 days in every month, and on eight of these days patients should have had a migraine, in order to be diagnosed with chronic migraine. There are around 700,000 such patients in the UK, Allergan estimates.

Botox continues to be a key product for Allergan, even though it has been marketed for more than 20 years. Its worldwide sales of around $331 million in the first quarter represented around a third of Allergan's total pharmaceutical sales of $907 million.

But it is facing competition from other neurotoxin products, like Medicis/Ipsen's Dysport , which was launched in the U.S. last year Also see "Class REMS For Botulinum Toxin Products Warns Against Interchangeabilty" - Pink Sheet, 30 April, 2009.), and Merz's product Xeomin , which is marketed in Europe.

The approval of the chronic migraine indication for Botox in UK is being followed by filings through the EU's mutual recognition procedure, with Ireland acting as the reference member state. Botox also has been submitted for approval in the U.S. for use in chronic migraine; Allergan expects to hear from the FDA in the second half of this year.

In a Phase III clinical program, called PREEMPT, patients treated with two cycles of prophylactic Botox had on average 8.2 fewer days of migraine when compared with the number of migraine days they had at baseline before therapy. Placebo-treated patients had on average 6.2 days fewer migraine days compared with baseline, a statistically significant difference.

Patients treated with Botox also had significant improvements from baseline in their quality of life (MSQ) scores and headache-related disability (HIT6) scores. Botox also is in development for the treatment of overactive bladder, and for benign prostate hyperplasia, and in March received U.S. approval for use in upper-limb spasticity in adults.

- John Davis ( j.davis@elsevier.com )

Allergan Continues To Find New Uses For Botox: Cleared For Chronic Migraine In The UK

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