FDA Approves Cefaly Migraine Prevention Device

Cefaly Technology says the FDA has approved its headache prevention device, also called Cefaly, for prescription-only sale in the United States.

Herstal, Belgium-based Cefaly is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain. It sends a small electric current to stimulate the trigeminal nerve. This stimulation reduces the number of migraine headaches.The Cefaly apparatus is a headband-like device worn for 20 minutes each day and requires no surgery or implantation. The user places a self-adhesive electrode to the center of the forehead, just above the eyes. The Cefaly rests atop this electrode, across the forehead and over the ears. The company says that the replaceable electrodes are each good for up to 20 treatments.The battery-powered Cefaly device generates precise micropulses of electricity that stimulate the nerve endings of the trigeminal nerve through the electrode. The company says that neurostimulation of the trigeminal nerve with the Cefaly produces a sedative effect, and regular repetition of this treatment helps reduce the number of attacks of migraine.The FDA says it reviewed data for Cefaly "through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device."The agency evaluated the safety and effectiveness of the Cefaly device based on data from a double-blind randomized clinical study in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month. Also examined were the results from a consumer satisfaction survey that garnered responses from 2313 Cefaly users in France and Belgium.The clinical study showed those who used the Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used the placebo device. However, FDA says the device did not completely prevent migraines and did not reduce the intensity of migraines that did occur. Findings were published in the journal Neurology in February 2013.The Cefaly company also conducted a consumer satisfaction survey. In this survey, 81 percent of regular users reported satisfaction with the Cefaly device. Regular users were characterized as patients who use the device according to medical recommendations. Results of this survey were published in The Journal of Headache and Pain in December 2013.Cefaly says the most common side effect of the device is intolerance to the feeling of the Cefaly on the forehead, said to occur in 1.25 percent of patients. The most severe is said to be an allergic skin reaction to the electrode, which happened in less than 0.25% of users.

According to FDA, migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head. They are accompanied by nausea or vomiting and sensitivity to light and sound and can last from four to 72 hours when left untreated. The National Institutes of Health says that migraine headaches affect approximately 10 percent of people worldwide and are three times more common in women than men.

Stephen Levy is a contributor to Qmed and MPMN.