FDA approves Botox for migraine
The U.S. Food and Drug Administration (FDA) said on Friday that it has approved the use of Botox, the anti-wrinkle medication, for treating chronic cases of migraine.
The announcement comes a month after Botox-maker Allergan settled with the agency for $600 million on charges of false marketing practices claiming that the product can treat other conditions which are unapproved by the FDA.
Botox can now be legally prescribed for migraines lasting 15 days per month as evaluated by physicians. The drug regulatory agency of the U.K. has already approved the use of Botox for migraines earlier this summer.
The FDA has long approved the well-known use of Botox for treating wrinkles as well as crossed eyes, excessive involuntary blinking, excessive underarm sweating, and muscle spasms or stiffness.
Botox had global sales of $1.3 billion in 2009 with roughly half of that amount coming from cosmetic treatments.
Allergan says that the medical use of Botox would soon overtake its use for cosmetic purposes. The pharmaceutical firm is researching the effectiveness of the drug in treating other medical conditions other than migraines.
“For the business, Botox has been an incredible medication. We call it our pipeline in a vial,” said Dr. Whitcup, executive vice president for research and development at Allergan.
“People still think about it as a cosmetic product, but the therapeutic indications in the next five years will far surpass its cosmetic use.”
By 2015, some observers predict that Botox for migraine treatments alone can generate up to $1 billion in yearly sales for Allergan by 2015.
Chronic migraine is differentiated from the average headache by other symptoms like nausea, vomiting, dizziness, hypersensitivity to noise and light and severe pain.