Allergan, Inc has completed a top-line analysis of its two phase-III clinical trials exploring the use of Botox (botulinum toxin type A) for the prophylactic treatment of headache in adults suffering from chronic migraine - that is, headaches and/or migraines that occur on 15 or more days each month.
Botox is the first therapy being investigated for this extremely debilitating condition of chronic migraine, which is estimated to affect between 1.2 and 3.6 million people in the United States1a,b.
"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, Allergan's executive vice president, Research and Development. "It is gratifying to focus our research and development efforts on an indication that addresses such an important unmet medical need."
Based on this top-line analysis of its two phase-III clinical trials, Allergan hopes to file a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) for the use of Botox in chronic migraine by mid 2009. Full data results are expected to be published or presented by mid 2009.
Botox is approved for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully.