The United States Food and Drug Administration (FDA) has approved Allergan Inc's anti-wrinkle injection Botox for treatment of chronic migraine.
Botox is the first clinically studied prophylactic (preventive)treatment to be approved by the FDA specifically for the problem.
It is estimated that chronic migraine impacts approximately 3.2 million Americans,(4)and can leave sufferers in pain for at least half of every month. The World Health Organization (WHO) ranks migraine as the 19th most disabling disease and notes that a day lived with severe migraine can be more disabling than blindness, paraplegia, angina (after walking 50 meters) or rheumatoid arthritis.
Although chronic migraine occurs in both men and women, women are three times more likely than men to suffer from migraines. Sufferers often experience depression and anxiety as part of the condition. Chronic migraine also can be influenced by life stress, sleep habits, diet and overuse of acute medications that relieve pain associated with symptoms of headache.
"Chronic migraine is a debilitating but under-recognized neurological condition. Often times, Chronic Migraine patients mistakenly self-diagnose their symptoms as headaches or infrequent migraine and treat them with drugs that provide rapid, but temporary, relief rather than seeking an evaluation, diagnosis and treatment from a qualified headache specialist," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "With Botox approved by the FDA for chronic migraine patients, there is now a new preventive treatment option to reduce the days and hours spent in pain as a result of this condition."
It is estimated that approximately 80 percent of those who meet the definition of chronic migraine have not received an accurate diagnosis and, as a result, may be unaware of their treatment options. This may be due to mischaracterization of chronic migraine as a less severe headache disorder.
Botox (onabotulinumtoxinA) was approved by the FDA based on data collected in Allergan's PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program. The program was designed to evaluate the safety and efficacy of Botox as a preventive treatment of headaches in adults with Chronic Migraine.PREEMPT is the largest clinical program in Chronic Migraine, consisting of two double-blind, placebo-controlled clinical trials involving 1,384 adults from 122 study sites in North America and Europe.
Botox was first approved by the FDA 21 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, Botox has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries.