The Food and Drug Administration (FDA) has granted 510 (k) approval to extend approval of gammaCore® (ElectroCore) to the acute and preventive treatment of migraines in adolescents 12-17 years of age. So far, gammaCore was only approved for this indication in adults.
The handheld portable device generates a low voltage electrical signal that creates an electrical field near the vagus nerve when it is placed on the neck. The expanded approval was based on previously reported randomized controlled trials with gammaCore in adults and on the results of a small study (n = 9) in adolescent patients. The results of the youth study showed that 46.8% (22/47) of the seizures treated were successfully resolved without the use of acute rescue medication.
Patients should not use gammaCore if they have an active implantable medical device (e.g. pacemaker, hearing aid implant), a metallic device such as a stent, bone plate, or bone screw implanted on or near their neck, or if they have any other device implanted use at the same time (e.g. TENS unit, muscle stimulator, or portable electronic device such as a mobile phone).
The device is only available with a prescription. More information on the prescribing process can be found here.
elektroCore Announces 510 (k) Clearance of Non-Invasive Vagus Nerve Stimulation (nVNS) from gammaCore ™ for the treatment of migraines in adolescents. [press release]. Rockaway, NJ: ElectroCore, Inc; February 16, 2021.
This article originally appeared on MPR
Migraines Migraines and Headaches Pain Pain Management Pediatrics