FDA approves Botox for chronic migraine

OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as a prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.

When injected at label doses in the recommended locations in the head and neck, Botox is expected to produce results that may last up to 3 months, depending on the individual patient.

It is estimated that chronic migraine affects approximately 3.2 million Americans. It can leave patients in pain for at least half of every month. Women are 3 times more likely than men to suffer from migraines.

Botox was approved by FDA based on data collected in Allergan’s PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program. PREEMPT is the largest clinical study of chronic migraine, consisting of 2 double-blind, placeco-controlled clinical trials involving 1,384 adults from 122 study sites in North America and Europe.

“The approval likely will mean a reduction in oral headache medications, an elimination of medication overuse syndrome [rebound], and less utilization of the emergency room as a treatment option,” said Peter J. McAllister, MD, a board-certified neurologist and clinical assistant professor of neurology at Yale University School of Medicine in New Haven, Conn.

“The approval is pertinent to not only neurologists and other headache specialists, but to the patients, whose lives are often severely disrupted, and their families,” added Dr. McAllister, who also serves as director of The Headache Center and director of clinical research at Associated Neurologists of Southern Connecticut in Fairfield, Conn.