The Food and Drug Administration (FDA) has cleared Cefaly Dual (Cefaly Technology) as an over-the-counter (OTC) device for acute and preventive treatment of migraine headaches in adults aged 18 years and older. Previously, the device was only available with a prescription.
Cefaly Dual is an external trigeminal nerve stimulator (eTNS) that sends electrical impulses through a self-adhesive electrode placed on the forehead to stimulate the trigeminal nerve, reducing the frequency and intensity of migraine attacks. The OTC clearance of Cefaly Dual was based on several randomized, controlled trials supporting its efficacy and safety. In a trial assessing acute treatment (N=109), 1 hour use of Cefaly resulted in significant headache pain relief compared with sham. Moreover, a significant decrease in the mean number of migraine days was observed with Cefaly compared with sham in a prevention trial involving 67 patients who experienced at least 2 migraine attacks per month.
The device has 2 settings: ACUTE and PREVENT. In the ACUTE setting, the device provides pain relief at the onset of or during a migraine attack for 60 minutes; the PREVENT setting reduces the frequency and intensity of migraine symptoms through 20-minute daily sessions. The device automatically turns off at the end of each session.
The Cefaly Dual Migraine Treatment and Preventive Kit is available at cefaly.com and currently costs $399.
Now over-the-counter: FDA clears Cefaly® Dual migraine treatment for use without a prescription. [press release]. New York, NY: Cefaly Technology; October 13, 2020.