The FDA has approved Botox (onabotulinumtoxinA, from Allergan) for the prophylactic treatment of headaches in adults with chronic migraine. This approval was based on data from the PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program which consisted of two double-blind, placebo-controlled clinical trials involving 1,384 adults.

In both PREEMPT studies, patients treated with Botox experienced a significantly greater decrease in the frequency of headache days from baseline compared to patients treated with placebo at the week 24 primary endpoint (7.8 and 9.2 fewer days for the Botox group, versus 6.4 and 6.9 days for the placebo group, respectively). Also at week 24, patients treated with Botox experienced a total cumulative reduction in headache hours by 107 and 134 hours, respectively, compared to 70 and 95 hours, respectively, in patients treated with placebo.

Botox is already indicated for the treatment of severe primary axillary hyperhidrosis, strabismus, blepharospasm, cervical dystonia, and increased muscle stiffness in elbow, wrist, and finger muscles with upper limb spasticity. Botox Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.

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