Migraines, Like Wrinkles, May Benefit from BOTOX

Can you imagine no more life interruptions due to migraines? Millions of people wish for this every day, and help may be on the way. The wrinkle eraser, also known as BOTOX®, has shown to relieve adult’s symptoms of chronic migraines. While BOTOX® isn’t currently indicated to treat migraines, within the next few years it could gain FDA approval.

Allergan, the BOTOX® distributor, announced recently the positive results of their Phase III study done on the effects of BOTOX® on patients with chronic migraines. During the trial, patients were divided into two groups who were given either BOTOX® or a placebo injection every 12 weeks. After two treatment cycles, the primary analysis was conducted. The efficiency of the injection was measured by two different ways: By the change in the number of headache episodes over the evaluated period, and the number of days patients suffered from a headache during the trial period. During the first of the Phase III trial, the company established the number of headache episodes to be the top factor to evaluate, and the secondary point of evaluation, as the number of days effected by a headache.

Though the results missed the mark in the first phase of the trial, with the BOTOX® group not reporting any more reductions in the number of headache episodes than the control group, it did demonstrate a great benefit in decreasing the number of days patients suffered from headaches in the BOTOX group compared to the placebo group.

After the first phase of the trial missed their primary goals, the primary objectives for the second part of the Phase III study was adjusted, to have the primary goal as reducing the number of headache days, and the secondary result be to reduce the number of headache episodes. During the second phase, both endpoints resulted in great benefits from the BOTOX® treatments, in comparison to the placebo, with both the number of days a headache lasted and the number of headache episodes being decreased.

Scott Whitcup, M.D., and Allergan’s Executive V.P., in Research in Development, said “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.” He also stated, “It is gratifying to focus our research and development efforts on an indication that addresses such an important unmet medical need.” 
Chronic migraines, headaches that affect a patient for 15 or more days throughout each month, affect millions of people throughout the United States. BOTOX® is the first method being evaluated to treat the debilitating condition.

Allergen is hopeful, based on their recent trial results, to file for a supplemental biologics license application with the FDA, to use BOTOX® in treating chronic migraines by 2009. If the company receives approval, and can market the product as a migraine treatment, sales of BOTOX® could increase to around $400 million by 2012.

If you are one of the millions whose daily life is affected by a migraine, you probably wouldn’t mind a little prick every few weeks to help relieve the symptoms. That may be possible in the next few years as more research and tests are conducted and approval is granted. However, a vial of BOTOX® can cost around $530 and you may need more than one for a headache treatment.