On the front page of its Business Day section, the New York Times reported, “The Food and Drug Administration on Friday approved Botox, the anti-wrinkle shot from Allergan, as a treatment to prevent chronic migraines, a little more than a month after the company agreed to pay $600 million to settle allegations that it had illegally marketed the drug for unapproved uses like headaches for years.”
Botox “had worldwide sales last year of about $1.3 billion, divided equally between medical and cosmetic uses.” But Allergan said “sales of Botox for chronic migraine and other medical uses would soon eclipse sales of the drug as a wrinkle smoother.
The Los Angeles Times “Booster Shots” blog reported, “The FDA’s decision expands the potential market for Botox, which burst upon the American cosmetic scene in the late 1980s, to 12% of the US population – the proportion of Americans thought to suffer from the throbbing, pulsating pain of migraine headaches.”
The approval allows Allergan “to advertise to consumers and promote to doctors the use of Botox for chronic migraine.”
The FDA “underscored Friday that Botox does not appear to be useful in treating or preventing less frequent migraines, or headaches that are not caused by the activation of nerve fibers within the brain’s blood vessels–the definition of migraine headache.”
The AP reported, “For the new use, doctors are directed to inject patients in the neck or head every 12 weeks to dull future headaches.”
The FDA “approved the new use based on two company studies of more than 1,300 patients who received either a Botox injection or a dummy injection.” Those “who received Botox reported slightly fewer ‘headache days’ than patients given the sham treatment. In the more significant of the two studies, patients on Botox reported about two fewer headache days than patients who didn’t receive the drug.”
Bloomberg News reported, “… the company settled a 2 1/2-year investigation of its Botox marketing that analysts said held up FDA approval for the migraine treatment.”
Allergan “pleaded guilty and was ordered by a judge to pay $375 million to resolve Justice Department allegations it promoted Botox for headache, pain and juvenile cerebral palsy from 2000 to 2005 without FDA approval.”
CNN reported, “The drug – whose generic name is onabotulinumtoxinA – has not been shown to work against migraines that occur 14 days or fewer per month, nor has it been shown to work for other forms of headache.”