FDA approves Botulinumtoxin (Botox / Allergan) for Headache Prophylaxis in Chronic Migraine
Again the indication list of Botulinumtoxin A has been increased....
The very powerful neuro toxin Botulinumtoxin A has found its way into the public by its use in Aesthetic Medicine to treat all kind of folds. The first approval by the FDA 21 years ago was for blepharospasm. Later followed the glabella folds and severe underarm sweatings called hyperhidrosis.
Today the FDA approved it for the prophylaxis of chronic migraine. The approval for chronic migraine was based on results of the phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) program, which was made up of 2 double-blind, placebo-controlled clinical trials that included 1384 adults from 122 centers in North America and Europe, a statement from Allergan notes.
The study showed that the number of days respectively hours in patients suffering from migraine has been significantly reduced. 2 % of the treated patients had side effect and adverse reactions against the material.
Source: Medscape Medical News
Author: Susan Jeffrey