The Food and Drug Administration (FDA) has cleared the external trigeminal nerve stimulator (Cefaly Dual; Cefaly Technology, New York, NY ) for the acute and preventative migraine treatment in individuals age 18 years or more without a prescription.
Initial purchase of the device is $400 and includes 20 doses (with a 60-day money-back guarantee), after that the cost is less than $0.50/dose. The migraine treatment stimulator and its prevention kit includes the device, a storage case, instruction manual, 1 electrode, power adapter, and charging cable. A standard electrode pack of 3 costs $25 and a hypoallergenic/blue gel electrode pack cost $35. The recommended number of uses for a single standard electrode is 20 and for a single hypoallergenic electrode is 10.
The over the counter clearance of the device will provide the nearly 39 million Americans living with migraine over-the-counter access to this convenient, nondrug, and noninvasive treatment option. The submission in support of this over the counter clearance of the stimulator was based on several randomized controlled clinical trials supporting the efficacy and safety of the device.
The stimulator is a noninvasive device placed on the forehead to modify pain sensation in the area research identifies as a center for migraine pain, the trigeminal nerve. The device offers 2 distinct treatment options, a 60-minute ACUTE setting that serves as an abortive treatment for pain relief at the onset of a migraine, which is clinically proven to stop or reduce migraine pain during an attack; and a 20-minute PREVENT setting for daily use to help prevent future episodes. The device comes with a 60-day money back guarantee.
"For millions of people across the US, living with migraine pain and coping with debilitating symptoms are daily realities. It's our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half," said Jennifer Trainor-McDermott, chief executive officer with CEFALY Technology.
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Omar Bushara, BA; Rimas V. Lukas, MD; and Jessica W. Templer, MD
Carlos E.V. Sollero, MD; Hsin-Pin Lin, MD; Miguel Chuquilin, MD; James Wymer, MD; and Aaron M. Carlson, MD