Image: Vancouver Laser and Skincare Center/Flickr
Botox isn’t just for wrinkles anymore. Thanks to FDA approval, Botox maker Allergan can now market the nerve-connection blocker to people with chronic migraines. This approval may double Botox’s annual sales, according to BusinessWeek:
The medicine, a purified form of the poison botulinum given as an injection, was cleared for people who suffer migraines at least 15 days a month, and whose pain lasts at least 4 hours, said Caroline Van Hove, an Allergan spokeswoman. About 3.2 million Americans meet those criteria, Van Hove said in a telephone interview yesterday.
The approval…came 10 days after the Irvine, California-based drugmaker pleaded guilty to charges it marketed Botox for unapproved uses, including pain. The medicine, which generated $1.3 billion in 2009 sales, may add $1 billion more in yearly revenue with the migraine indication, said Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, in a May report.
“This is the most meaningful market expansion that the product has had since it was approved for cosmetic use” more than 20 years ago, said David Amsellem, an analyst with Piper Jaffray & Co. in New York who rates the shares “overweight.”
To treat migraines, Botox is given every 12 weeks in multiple injections around the head and neck to reduce future symptoms, the FDA said. The drug hasn’t been shown to work for other types of headaches, or for migraines that occur less frequently than 15 days a month, the agency said.
This kind of additional treatment approval is every pharma company’s fantasy, though I question whether migraine usage with be popular enough to increase revenue as much as analysts suggest (the botulinum toxin already has a variety of other lesser-known uses, including treating muscle spasms). The benefits of Botox vs. a placebo in the migraine study weren’t that dramatic.
I can’t help but wonder if those injection sites happen to correspond with the forehead, area around the eyes, and other convenient wrinkle-removal locations. Then those analysts would be onto something.