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New Study Shows Botox Helpful for Migraines

Posted: September 15, 2008

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A spokeswoman for the company said it wants to take the time to fully evaluate the data. She said the company will file an application in Canada and Europe shortly after filing with FDA. A mid-2009 FDA filing, she said, could mean U.S. approval by the first half of 2010. "There's certainly quite a bit of off-label use in headache now," said Dr. David Simpson, neurology professor at the Mount Sinai School of Medicine. "I suspect to the extent that this information is public, it would increase both the knowledge and clinical willingness to use it. But at this point, it's just a press release. None of us have seen the data yet." He noted that in May 2008, the American Academy of Neurology concluded that botulinum toxin type A was not an effective treatment for chronic headache.

Biegelsen said current off-label use of Botox for migraine accounts for about $50 million, or about 5%, of total Botox sales. If Allergan gets the migraine indication, migraine sales could increase to about $400 million by 2012. The company declined to estimate the size of the market for migraine treatments.

By Debra Sherman, Reuters, September 11, 2008