The U.S. Food and Drug Administration (FDA) has approved the marketing of a device, called Cefaly, which would serve as an alternative medication for migraine to those who find existing medications ineffective.
Migraines are severe headaches that are accompanied by sensitivity to light, smell, and sound. If not properly treated immediately, this could last from hours to days. It is known to affect about 10 percent of individuals around the globe, according to the National Institute of Health.
There is no specific treatment for migraines, but some resort to taking Nonsteroidal anti-inflammatory drugs, which sometimes work efficiently. At times, patients who frequently experiences migraines are prescribed with antidepressant, antihypertensive, and anti-seizure drugs. However, most often than not, taking these drugs are futile.
After evaluating a study conducted in Belgium, which included a total of 67 individuals who had a couple of migraine attacks per year, they found no serious adverse effects associated with the use of the device. This led the FDA to approve the alternative treatment for migraines on Tuesday.
Cefaly, which is manufactured by STX-Med in Herstal, Liege, Belgium, is the first transcutaneous electrical nerve stimulation (TENS) device approved by the federal agency. It is purposely devised to use before the onset of migraine.
"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 the FDA's Center for Devices and Radiological Health in a press release.
It is a small, portable, battery-operated device that is placed across the forehead and on the ears. It works by generating an electric current to the skin and underlying body tissues. The electric current will stimulate branches of the nerve associated with migraines, called the trigeminal nerve. Once working, the patient will feel a tingling sensation where the self-adhesive electrodes are placed.
Additionally, the prescription device is meant to be used by individuals 18 years and above, and must only be used for 20 minutes once a day.
