There are about 3.2 million Americans that suffer from migraine headaches, that is a headache that persists for four to 72 hours and involves sensitivity to noise, odors, and lights. Chronic migraines can be severely disabling to the suffer and have an impact on work, family, and social functioning. Sadly, many migraine suffers don’t respond well to traditional treatments and medications.
Botox, Onabotulinumtoxin A injection, has been used to smooth frown lines for the last 20 years. However, in recent years, it’s also been used to relieve the symptoms of cervical dystonia, strabismus, blepharospasm, muscle stiffness in the upper extremities, and to control underarm sweating. And, it’s long been investigated as a treatment for migraine headaches. Last July, the U.K. added migraine headaches to their list of cleared uses for Botox.
The road in the U.S. has been much longer and hard paved than Botox approval for migraines in the U.K.
Allergan, the maker of Botox, underwent a 2 ½ year investigation that drastically slowed down the drug being approved for migraine treatment in the U.S. It wasn’t until October 5, 2010 that Allergan finally resolved allegations that they promoted Botox in 2000 through 2005 for uses not approved by the FDA. Although Allergan was ordered to pay a $350 million criminal fine and forfeit $25 million in assets, the company has much more to gain from Botox being approved for the treatment of migraine headaches.
On October 15, 2010, just 10 days after Allergan pleaded guilty to the above investigation, the FDA approved Botox for patients who experience at least fifteen days of migraine headaches per month. By October 18, 2010, Allergan shares rose to $71.87 per share, a 4.4% ($3.00) increase. Botox is already Allergan’s top selling drug and accounts for about ¼ of the company’s total yearly sales. Projections show that adding migraines as an approved use could double annual Botox sales to about $2.3 billion. It’s also important to note that Allergan is expecting migraines to become an approved Botox use in Canada, which would further boost projected sales.
Botox, for migraine headaches, will be given every 12 weeks through multiple injections around the neck and head.
Botox has been shown to treat and prevent migraines by blocking nerve connections. In Allergan-funded research, chronic migraine patients that took Botox had 7.8 fewer “headache days” when compared to the 6.4 fewer headaches reported by those taking a placebo. Outside research actually showed even better results – 9 fewer headaches per month on Botox vs. 6.7 fewer headaches on a placebo.
The FDA made it clear in their release that Botox hasn’t been proven to work on other types of headaches or migraines that don’t occur at least 15 days per month. See here for more information on migraine headache symptoms, causes, and diagnosis.
It’s important to note that just last year the FDA ordered all botulinum products to strengthen their black box warning that toxins may cause life threatening breathing or swallowing difficulties, much like botulism would, if the toxins spread past the injection site. Some consumers might not be aware of this, but botulinum products, including Botox, is actually derived from the same bacteria that causes botulism.
Headache and neck pain were the most common adverse reactions reported by those being treated with Botox for migraine headaches.