FDA Approves First Device to Prevent Migraines
TUESDAY, March 11, 2014 -- The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines.
The device, called Cefaly, is a headband-like device that runs on a battery and sits across the forehead and over the ears, the FDA said in a statement.
"The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode," the agency explained. "The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches."
Cefaly is made by Belgium-based Cefaly Technology and is available by prescription only. The device is only indicated for use by adults and should only be used for 20 minutes per day, the FDA said. The agency also noted that "the user may feel a tingling or massaging sensation where the electrode is applied."
One migraine expert welcomed news of the device's approval.
"This device is a promising step forward in treating migraine headaches, as it addresses an important part of what we believe triggers and maintains a migraine attack," said Dr. Myrna Cardiel, clinical associate professor of neurology at NYU Langone Medical Center and NYU School of Medicine in New York City.
She added that the rate of positive response to the Cefaly device "appear to be comparable to what we see with most oral migraine preventive medications."
Millions of Americans are afflicted by migraines, which typically involve intense, throbbing pain in one side of the head, along with nausea, vomiting and a sensitivity to light and sound. According to the U.S. National Institutes of Health, about 10 percent of people worldwide complain of migraines, with women affected three times more often than men.
The FDA said Cefaly's approval was based on the results of a clinical trial in Belgium involving 67 people who had more than two migraine attacks per month and who had avoided medications in the three months prior to trying the device. Compared to people using an inactive placebo device, people who used Cefaly had "significantly fewer" days spent battling migraines compared to nonusers. They also had less need for migraine medications, the FDA said.
Approval was also based on a "patient satisfaction study" of more than 2,300 Cefaly users in Belgium and France. That study found that 53 percent of people who tried the device said they were satisfied with it and would buy one for continued use.
The cost of the device in the United States is not known yet, but it sells for about $300 in Canada, according to the company's Canadian website.
Some of the study participants did say they disliked the feeling of using the device. Others complained of sleepiness during the treatment session, and headache after the treatment, the FDA said. No serious side effects were reported.
Find out more about migraines at womenshealth.gov.
Posted: March 2014