FDA Approved Botox Therapy For Chronic Migraine
Chronic migraine is a distinct and relatively recently defined sub-type of Chronic Daily Headache. It is generally defined as causing more than fifteen headache days per month over a three month period of which more than eight are migrainous, in the absence of medication over use. Episodic migraine is the other migraine sub-type, which is defined as less than 15 headache days per month.
The impact of chronic migraine can be very disabling. Being incapacitated for over half the month sometimes means that people are unable to work at all, with some claiming disability living allowance.
While pain killers and other therapies can often take the edge off, full relief was not available for all who suffer from this excruciating condition until the FDA approved Botox for this purpose.
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. The PREEMPT studies were published in the March 2010 issue of Cephalalgia.Botox is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. Botox has a unique, protected molecular structure that stabilizes the core toxin in Botox from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, Botox neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three months depending on the individual patient. In the PREEMPT studies, none of the study participants suffering from Chronic Migraine demonstrated neutralizing antibodies to Botox at study completion.
Those who suffer from chronic migraines complain of headaches for more than half the month. Treatment options for pain management of acute symptoms often come in the form of medication, recommended or prescribed by a physician. However, those with chronic migraines are encouraged to take medication to prevent the frequency of pain. For those who want the possibility of a better solution, FDA has now approved Botox injections.
“When you are getting headaches, chronic migraines more than half of the month you may want to consider Botox injections, which is currently the only FDA-approved treatment option. It is given as a series of injections by your healthcare provider every three months to try to reduce the frequency of headaches by 8-9 less per month,” said Dr. Jessica Ailani, Director of The Medstar Georgetown Headache Center in Washington, D.C.
