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Botox approved to treat migraine

MHRA approves botulinum toxin as a treatment for chronic migraine, after study results show it reduces frequency and severity of migraine

Botulinum toxin (Botox, Allergan) has been approved as a treatment for chronic migraine by the UK's Medicines and Health Regulatory Agency (MHRA). The approval follows study findings that injecting the toxin is associated with a reduction of migraine frequency, migraine severity, acute medication usage, and associated vomiting.

Tests of Botox for this indication were instigated more than a decade ago based on anecdotal reports from people receiving Botox treatments for cosmetics purposes who had found that their migraines eased.

In the latest trial, more than 1300 participants received five injections at 12-week intervals, with a withdrawal rate of almost 4 per cent. Over the course of one year, almost 70 per cent of patients receiving Botox treatment experienced a reduction of up to 50 per cent in migraine frequency.

The UK is the first country in the world to approve Botox as a treatment for migraine. The National Institute for Health and Clinical Excellence (NICE) will now assess the treatment to determine whether it will be reimbursed by the NHS.

Following approval of the treatment for the chronic migraine indications, eligible patients – adults suffering from headaches for at least 15 days each month, of which at least eight days are with migraine, including sensitivity to light, nausea and numbness – will now be able to receive a series of approximately 30 injections in their head and neck muscles every three to six months.

As well as a cosmetic treatment to reduce the appearance of wrinkles and reduce perspiration, Botox is also used in the treatment of cerebral palsy, back pain, facial ticks and squints, and is under investigation for the treatment of over-active bladder.

12th July 2010

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