Botox for Migraine
Ten percent of the American population is actively afflicted by migraine, and about 2% suffer from a variant of that primary headache disorder – which often diminishes one’s quality of life. Thus, 1 in 50 Americans upwards of 6 million individuals, suffer from daily or near-daily headaches that are migrainous in origin. Not surprisingly, this chronic variant accounts for a disproportionally high share of the public health burden imposed by migraine generally. Unfortunately, most of the therapies that may be effective in reducing the frequency of headache attacks in individuals with episodic migraine have exhibited little or no meaningful effect in suppressing chronic migraine.
For more than 10 years John F. Rothrock, MD, director of the UAB Headache Treatment and Research Program, has been working with colleagues internationally to investigate the safety and utility of botulinum toxin-type A (onabotulinumtoxinA: onabotA) in the treatment of headache, and in October 2010 their efforts culminated in the Food and Drug Administration (FDA) approving onabotA specifically for the treatment of chronic migraine. OnabotA is the only therapy possessing an FDA indication for treatment for this common and vexing disorder.
First Came Sumatriptan
“Self-administered injectable sumatriptan, initially available only as Imitrex and now available as a generic, represented the first great breakthrough in migraine therapeutics,” says Rothrock. “That drug’s introduction 20 years ago empowered millions of individuals with migraine who previously would have had to seek medical attention for their acute attacks – or simply suffer in silence at home – instead to treat themselves safely, rapidly, and effectively. As injectable sumatriptan was to acute migraine treatment, so now onabotA is to the suppression of chronic migraine, the most common headache disorder encountered at subspecialty clinics devoted to headache.”
Administration of onabotA requires 31 to 37 injections of the drug at muscle sites over the forehead, temples, back of the head, neck, and shoulders. When performed by an experienced physician, the entire procedure requires no more than 5 minutes. “There is definitely some discomfort associated with the injections,” he says, “but the payoff in headache relief far outweighs the discomfort for the vast majority of patients.”
Most patients with chronic migraine who are destined to respond to onabotA will do so following the initial set of injections, but it may take up to 2 weeks for those patients to begin to notice any improvement. Sets of injections initially are repeated at intervals of approximately 3 months, and many responders note that with each successive treatment they experience an increasingly prominent decrease in headache frequency and severity. Although it is unknown how long patients with chronic migraine typically will require repeated sets of onabotA injections, results of preliminary research conducted by Rothrock and his UAB team suggest that many eventually will be able to discontinue injection therapy and remain headache-free or nearly so for an extended period. (Andress- Rothrock D, Scanlon C, Weibelt S, Rothrock J. OnaboutlinumtoxinA in the treatment of chronic migraine: long-term outcome. Accepted for publication in Headache.) A national study to examine this issue and the long-term safety of onabotA therapy for chronic migraine is in the last stages of planning, and UAB will serve as one of the participating sites in that study.
OnabotA appears to be a remarkably safe therapy for chronic migraine and is easily tolerated. While patients occasionally experience transient drooping of an eye lid or a “wobbly” neck for some weeks following injection therapy, very few discontinue treatment as a consequence of side effects.
OnabotA is a relatively expensive drug, and in these lean times the question naturally arises: Does the clinical effect of onabotA injection therapy for chronic migraine justify the treatment costs? Preliminary work by Rothrock and his team indicate that this treatment will more than pay for itself. In October 2009, at the annual Controversies in Neurology conference held in Prague, Rothrock presented the results of a study conducted at UAB which demonstrated that the savings resulting from decreased emergency room utilization for acute headache treatment will be sufficient to pay for the cost of onabotA injection therapy in responders and nonresponders alike. “It’s extremely gratifying to have – at last – a therapy to offer this unfortunate patient population,” says Rothrock.
“This is especially so when it’s a therapy that’s safe, well-tolerated, clinically effective, costeffective, and can be administered every few months rather than on a daily basis.”