The United States FDA last week approved Botox, the anti-wrinkle shot from Allergan, as a treatment to prevent chronic migraines. This came after the company agreed last month to pay $600 million to settle allegations that it had marketed the drug for off-label uses for years.
The FDA’s decision endorses doctors’ use of Botox to treat patients who suffer from a severe form of migraine involving headaches at least 15 days a month. Botox is already approved by the FDA to treat blepharospasm, strabismus, hyperhydrosis, cervical dystonia, and muscle spasticity in the upper extremities. It is widely known as the most popular wrinkle smoother on the planet and is approved for cosmetic purposes to treat glabellar furrows between the eyebrows. Interestingly, Allergan projects that sales of Botox for chronic migraine and other medical uses would soon exceed sales of the drug as a wrinkle smoother… but I’m not so sure of that. Often insurance companies do not pay for medical uses (including treatment of migraines), and the out of pocket expenses can be quite high. Cosmetic patients expect such treatments to be an out of pocket expense and can typically afford it.
A Botox migraine treatment generally involves a total of 31 injections in seven areas — including the forehead, temples, the occipital area, the neck and shoulders. To treat chronic migraine headaches, injections are given about every three months. There was some question about whether the FDA would want more medical evidence because one of two studies used to bolster Allergan’s migraine application failed its main goal. Allergan said that the FDA was most interested the secondary goal of reducing headache days, however, where that study showed success was in treating migraine pain episodes.
Adverse reactions for patients in those studies included headaches, migraines, eyelid drooping, muscle weakness and some other conditions.
Allergan said the effects of Botox for migraine treatment last up to three months per treatment, about the same for other uses such as wrinkle ablation by injecting between the brows. It is great that there is now another approved treatment for such a debilitating condition as migraine headache, but I truly doubt that Botox for medical usage such as this one will ever eclipse the sales and use of it for treatment of wrinkles given its enormous popularity in that sector.