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Botox showed a statistically significant benefit for Botox over placebo. Without a headache indication the company can not promote data as U.S. Department of Justice is already investigating the off-label promotion of Botox for migraine. Allergan is said to be fully cooperating. Still, favorable data in studies will make physicians more likely to try it on patients suffering from migraines.
Botox costs $525 a vial, and 1.5 vials were used to treat headaches in the studies. Dr. David Simpson, a neurology professor at Mount Sinai School of Medicine, says there is a lot of off-label use in headaches now. He noted that in May of 2008, The American Academy of Neurology concluded that botulinum toxin type A was not an effective treatment for chronic headaches.
Biegelsen says current off-label use of Botox for migraine accounts for about $50 million, or 5% of total Botox sales and if Allergen gets the migraine indication, he believes sales could increase to about $400 million by 2012.
Mark A Bishara, M.D., P.A. Medical Director
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