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Botox approved for chronic migraine

The US Food and Drug Administration has approved Allergan's Botox injection for the prevention of headaches in adults with chronic migraine

The US Food and Drug Administration (FDA) has approved Allergan's Botox injection (onabotulinumtoxinA) for the prevention of headaches in adults with chronic migraine, a debilitating condition in which patients experience a headache more than 14 days each month, with headaches lasting four hours or longer.

Botox, a neurotoxin that works by immobilising muscles, is used to treat chronic migraine through 31 injections administered across seven sites around the head and neck, which are given about every 12 weeks.

The drug is the first clinically studied prophylactic treatment to be approved by the FDA specifically for chronic migraine. Allergan estimates that about 3.2 million Americans suffer from chronic migraine and that about 80 per cent have not received an accurate diagnosis.  The FDA noted that Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other kinds of headache.

The approval was based on two phase III clinical trials involving 1,384 adults from 122 study sites in North America and Europe. The results, which were published in the March 2010 issue of the medical journal Cephalalgia, showed that patients treated with Botox saw their frequency of headache decrease by 7.8 days in one study and 9.2 in the second study by week 24, versus 6.4 and 6.9 days for the placebo group. The Botox group also had a greater reduction in total hours of headache.

Botox was first approved by the FDA 21 years ago for the treatment of certain eye muscle disorders and has since been approved to treat symptoms of cervical dystonia, symptoms of severe underarm sweating, and stiffness in the elbow, wrist, and finger muscles in patients with upper limb spasticity. In addition, Allergan markets the product as Botox Cosmetic for the improvement of facial lines.

18th October 2010


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