Allergan Inc., the Botox distributor, said that its popular anti-wrinkle Botox injection may work as a treatment for adults suffering from chronic migraines, according to the results of their Phase III clinical trials done on the effects of Botox on patients with chronic migraines. During the trial, a group of patients was given a Botox injection every 12 weeks and the others were given a placebo injection. Data obtained at the end of the study showed a significantly greater decrease in headache days among patients receiving Botox, compared with those receiving a placebo.

"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, Allergan’s EVP, in Research and Development.

Migraines are cause by an abnormality in brain chemistry; recent studies found that activity in the hypothalamus gland was associated with an attack. Such attacks last up to 72 hours and are characterized by pulsating headache, nausea and vomiting and sensitivity to light. Migraines occur most often between the late teenage years and the age of 50, and it is thought that every day more than 100,000 sufferers miss school or work because of migraines. Chronic migraines and headaches, which are symptoms of migraines, affect millions of people throughout the United States.

The company hopes to fill an FDA application in order to use Botox injection in chronic migraine by mid-2009. Earlier this year, the Academy of Neurology concluded that botulinum toxin type A was not an effective treatment for chronic headache.

If the company receives approval, and can market the product as a migraine treatment, sales of Botox could increase to about $400 million by 2012.