March 11 The U.S. Food and Drug Administration said on Tuesday it approved a nerve-stimulating device to prevent migraines that is worn as a band across the forehead.
The battery-powered device, which should be positioned above the eyes, sends an electric current to the skin and underlying tissue via a self-adhesive electrode to stimulate the trigeminal nerve that is associated with migraines.
Manufactured by Belgium-based CEFALY Technology SPRL, the prescription-only device is intended for use once per day for 20 minutes.
FDA said it was the first medical device to be approved as a preventive treatment for the severe headaches.
"This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.
About 10 percent of people worldwide suffer from migraines, according to the National Institutes of Health. Characterized by intense pain in one area of the head accompanied by nausea or vomiting and sensitivity to light and sound, a migraine can last from four to 72 hours if untreated.
Drugs to treat migraines called triptans, which include generic forms of GlaxoSmithKline Plc's Imitrex (sumatriptan), have cardiovascular side effects that make them inappropriate for many patients and for long-term use. The CEFALY device is for patients 18 and older.
FDA said in a clinical study of 67 patients in Belgium, those who used the device had significantly fewer migraines per month and used less medication than those who used a placebo device. The device did not reduce the intensity of migraines that occurred.