The FDA recently approved Botox, a wrinkle-smoothing injection, for the treatment of migraine headaches. Drug maker Allergan has now been given the go ahead to market its drug to patients with a serious history of migraines. This announcement comes just one month after Allergan agreed to pay more than $600 million to settle claims that they had been illegally marketing the drug for years through the promotion of off-label use.
However, the use of Botox injections isn’t for the occasional migraine sufferer. The FDA has only approved the drug for patients who experience 15 or more migraine headaches a month. Migraines are crippling to most sufferers, and the effects are more than just a headache. Chronic migraine sufferers also have nausea, vomiting, dizziness, sensitivity to light and noise, and severe pain. According to Allergan, more than 3.2 million Americans have chronic migraines.
“This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” said FDA’s Dr. Russell Katz, director of neurology products.
Dr. Scott M. Whitcup, Allergan’s executive vice president for research and development, has said that the company is studying the use of Botox for other medical conditions such as overactive bladder. “For the business, Botox has been an incredible medication,” says Whitcup. “We call it our pipeline in a vial. People still think about Botox as a cosmetic product, but the therapeutic indications in the next five years will far surpass its cosmetic use.”
Whitcup says that one theory on why the drug works on migraines is that it “blocks pain signals from reaching nerve endings.” Since Botox is a form of botulinum toxin, injections of the drug can numb nerve signals which send pain signals to muscles and glands. Researchers suggest that injections should be given every three months to treat the migraines and patients are usually given 31 injections in seven areas of the body including the forehead, temples, back of the head, neck and shoulders to help relieve migraine pain.
However, costs may prevent many from being able to afford the injections. Makers of Allergen estimate that the treatment would cost between $1,000 – $2000 and although most insurance companies may cover the procedure because of the new FDA approval, the co-pays may be heftier than most can manage.
“The cost is prohibitive for some,” says Randall Stanicky, a vice president for global research at Goldman Sachs. “But given the debilitating challenges of having migraines more than 15 days a month, if Botox can cut down on that, it’s clearly going to be a big opportunity.”
Botox is currently also being used to treat spasms in the elbows, wrists and fingers, uncontrolled blinking, excessive underarm sweating, and its most well-known use, to reduce wrinkles. Botox was introduced in 1989 and is one of Allergan’s top drugs accounting for over 25% of sales; 1.3 billion of the company’s $4.4 billion sales in 2009.
It is important to also understand that Botox may present risks in patients including respiratory failure and death. The FDA’s safety reviews say “the reactions may be related to overdosing, but there is no evidence that reactions are caused by a defect in the product.”