Botox approved for chronic migraine

12th July 2010 - Well known in the fight against wrinkles, Botox has now been approved by UK regulators to tackle chronic migraine.

Bbotulinum toxin type A - better known as Botox - has been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) to help keep away headaches for adults who have chronic migraine.

Migraine Action says one in seven people in the UK suffer from migraine, affecting twice as many women as men.

Treatment

The treatment criteria says patients have to have experienced headaches for 15 or more days a month, with migraine on at least eight of these days.

The treatment was licensed after a clinical trial called the PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) clinical programme. This consisted of two randomised, double-blind and placebo controlled studies involving more than 1,300 patients diagnosed with chronic migraine.

Participants were given either Botox injections or a dummy treatment for 24 weeks, and then all patients received Botox until the end of the 56 week study.

Patients in both groups had an average of around 19 days with migraine. The Botox group had an average of 8.2 fewer migraine days at week 24, the placebo group had 6.2 fewer migraine days.

The Botox patients had significantly fewer headache days compared to those patients treated with placebo - 47.1% compared to 35.1%.

At the end of the second phase of the trial, week 56, nearly 70% of patients treated with Botox experienced a better than 50% reduction migraine days.

The study concluded that Botox was generally well-tolerated and an effective preventative treatment for adults with chronic migraine, giving improved quality of life and reduced headache related disability.

Reaction

The chairman of Migraine Action's Medical Advisory Board, Dr Andy Dowson says in a news release: "The licence for Botox in chronic migraine is welcome. For headache there have been very few new options made available in the last five years despite the huge effort from scientists and the Pharmaceutical industry to make breakthroughs in the field.”

“Botox has been used 'off licence' in private practice for quite some time (nearly 10 years in my case).

“We do need to develop a skilled group of injectors and encourage the wider NHS to offer Botox as an option to appropriate individuals. It is always a good day for a headache sufferer when a new treatment option becomes available."

Lee Tomkins, Director at Migraine Action says, "The licence of Botox as a preventative treatment for chronic migraineurs is a really important step forward. Chronic sufferers are always aiming to get more "crystal clear" headache-free days each month and this treatment will help them to achieve that. Botox will give many chronic migraineurs a new lease of life where individuals will be able to make more plans and not be so debilitated by their condition."

Migraine Action makes it clear the treatment should only be given by trained health professionals, not those who typically administer it for cosmetic purposes.