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FDA Approves Botox for Migraine

by Teri Robert, Lead Expert

The FDA has now approved Botox (onabotulinumtoxinA) for the treatment of chronic Migraine. Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, stated,

"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."1

To treat chronic Migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck. So far, Botox has not been shown to work for the treatment of episodic Migraines that occur 14 or fewer days per month.

In the indications and usage section of the Botox prescribing information, the FDA approval results in the addition of this indication for Botox:

"Chronic Migraine
Prophylaxis of headaches in adult patients with chronic migraine (≥15 [15 or more] days per month with headache lasting 4 hours a day or longer.)"

For those who are curious about the dosage and administration of Botox for chronic Migraine, here is some information from the prescribing information:

"The recommended dilution is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL (see Dilution Table). The recommended dose for treating chronic migraine is 155 Units administered intramuscularly (IM) using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams and Table 1 below. A 1 inch needle may be needed in the neck region for patients with thick neck muscles. With the exception of the procerus muscle, which should be injected at 1 site (midline), all muscles should be injected bilaterally with half the number of injection sites administered to the left, and half to the right side of the head and neck. The recommended retreatment schedule is every 12 weeks."

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