AnabotulinumtoxinA, a botox injection for people who experience migraine headaches on most days of the month - chronic migraine - has been approved in the USA by the Food and Drug Administration (FDA). According to the FDA, a migraine headache is a strong, pulsating pain in a specific area of the head, often accompanied by nausea, photophobia (sensitivity to light), sonophobia (sensitivity to sound), and sometimes vomiting. Women are three times more likely to suffer from migraines than men. Although most patients who get migraines do so intermittently, some develop disabling chronic migraine which is present for more than 50% of the days of each month, lasting four hours a day or longer.
The therapy has been approved as prophylactic (preventive) treatment.
Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said:
Chronic migraine is one of the most disabling forms of headache. Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.
Multiple Botox injections, administered around the head and neck, have been found to be effective in dulling chronic migraine symptoms. However, it is not effective for patients with episodic migraine (occurring less than 14 days per month), neither is it effective for other non-migraine types of headaches. The FDA stresses that patients should talk to their doctors about what is the best treatment for them, and whether Botox is the right therapy.
Botox and Botox Cosmetic - the brand names for OnabotulinumtoxinA - are manufactured by Allergan Inc., Irvine California. There is a boxed warning explaining that Botox's effects can spread to other parts of the body and cause botulism-type symptoms, which may include breathing and swallowing difficulties; these can sometimes be serious and life-threatening.
The FDA adds that there are no reports of serious cases of the toxic effect of Botox spreading to other parts of the body when it has been administered with the right dosage for chronic migraine, excessive sweating under the arms, strabismus, or the improvement of frown lines.
According to Allergan, when injected at the indicated dosages in the specific areas in the head and neck, Botox should produce results that last up to three months, depending on the individual patients.
About 3.2 million individuals in the USA are thought to suffer from chronic migraine. According to the World Health Organization (WHO), chronic migraine is the 19th most disabling disease there is; severe migraine has been described by experts as more disabling than angina, rheumatoid arthritis, blindness and paraplegia.
Patients with chronic migraine are significantly more likely to also suffer from depression and anxiety. The condition can be influenced by sleeping habits, diet, overusing acute pain relieving medications, and stress.
Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer, said:
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. With BOTOX(R) 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.
Source: Allergan, FDA
Written by Christian Nordqvist