Allergan, Inc has received United States Food and Drug Administration (FDA) approval for Botox (onabotulinumtoxinA) for the prophylactic (preventive) treatment of headaches in adults with chronic migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer. Botox is the first clinically studied prophylactic treatment to be approved by the FDA specifically for this debilitated patient population. When injected at labelled doses and in the recommended locations in the head and neck, Botox is expected to produce results lasting up to three months depending on the individual patient.
It is estimated that chronic migraine impacts approximately 3.2 million Americans, 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, 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 diagnosis8 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.
"Patients who think they may have chronic migraine should seek advice from a medical specialist, such as a neurologist, headache or pain physician, who is qualified to evaluate, diagnose and properly manage this condition and see if Botox treatment is right for them," said Sheena K Aurora, director, Swedish Headache Center, Seattle, Washington. "Effective management of the chronic migraine patient requires an analysis of headache type, triggers, co-morbidities and current medications to develop an appropriate treatment plan. The FDA approval of Botox offers a new, clinically evaluated and proven option to help Chronic Migraine sufferers reduce the number of hours and days they suffer from headache for up to three months per treatment."
When treating chronic migraine, qualified medical specialists administer 31 injections of Botox neurotoxin into seven specific head and neck sites for a total of 155U per treatment session.
Botox is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.