"We are pleased with the top-line results of our Phase III clinical trials which show that Botox treatment provided benefit to these patients whose lives have been profoundly impacted by this severely debilitating condition," said Scott Whitcup, MD, and Allergan's Executive Vice President, Research and Development.
California-based Allergan will now seek U.S. Food and Drug Administration’s approval to market Botox for headaches. By middle 2009, the company hopes to file a supplemental Biologics License Application (sBLA) with the FDA.
Botox (botulinum toxin type A), a neurotoxin protein produced by the bacterium Clostridium Botulinum, is one of the most poisonous naturally occurring substances.
Used properly, Botox is helpful in treating cervical dystonia, nerve and muscle spasms and excessive armpit sweating besides its most common use in cosmetic operations. The new therapy is expected to provide relief to an estimated 1.2 million to 3.6 million people in the United States suffering from chronic migraines.
The study volunteers’ injected with Botox reported significantly fewer migraine days compared with those who received placebo injections. However, the therapy was accompanied with side effects including pain, tenderness and bruising at the site of injection.
The full results of the study will be published next year.
About Migraine
Migraine, a neurological syndrome typically characterized with one-sided pulsating headaches lasting 4 to 72 hours, nausea and vomiting, commonly affects more women than men. The treatment of migraine begins with simple painkillers for headache and anti-emetics for nausea.
Experts believe avoiding the factors that trigger the attack to be the key to handling migraine. While chocolate, stress, alcohol, lack of sleep, hormonal fluctuations and sex (for some) can trigger the attack, caffeine is deemed to be the cheapest and the most available drug to treat migraines.
Evidence confirms alternative medical treatments like biofeedback, ice massage, yoga and acupuncture to be helpful in relieving migraine pain.
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