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MEDICAL TRIALS
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Allergan aims to stop migraines with BOTOX

Irvine-based Allergan Inc. has finished an analysis of its Phase III clinical trials for the use of BOTOX to treat headaches.

By Kristen SchottPublished: September 10, 2008 10:09 AM

Allergan's two Phase III clinical trials tested BOTOX use in the treatment for victims of chronic migraines – headaches that occur 15 or more days each month. Migraines affect between an estimated 1.2 million and 3.6 million U.S. inhabitants on a monthly basis.

During the tests, patients were given random BOTOX or placebo injections every 12 weeks. These were studied at week 24 after two treatment cycles. Both trials found victims tolerated the injections, and those who received BOTOX had a significant improvement in their quality of life, as opposed to those who took placebos.

Based on those findings, Allergan wants to file a biologics license application with the U.S. Food and Drug Administration to use BOTOX in chronic migraine medication by mid 2009.