FDA Clears Remote Neurostimulator for Acute Treatment of Migraine in Adolescents
The Food and Drug Administration (FDA) gave clearance for a therapeutic remote electric neuromodulation (REN) device (Nerivio; Theranica, Netanya, Israel) for the expanded indication of acute treatment for migraine in adolescents. Efficacy of the device for treating migraine in adolescents is supported by a study published in Headache (Table). There were no device-related serious adverse events.
Dr. Jennifer McVige, a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at the DENT Neurologic Institute, who was one of the investigators in the clinical study which led to this indication expansion. "Teens do not always want to take pills, and some may be unable to do so due to various contraindications. Additionally, teens tend to easily adapt to tech. Nerivio is an efficacious smartphone-controlled tech solution that can be worn inconspicuously and is the perfect design for teens who may unfortunately begin to experience migraine attacks. As a mother of two teenagers with migraine, and someone who sees many adolescents in my practice, Nerivio is a promising new option with potential to help thousands of young patients."
The REN device is available through a licensed healthcare provider’s prescription. The device has direct delivery to an individual’s home. Each device unit is usable for 12 treatments, after which it can be recycled.
"This new indication is a dramatic step in our committed effort to serve the migraine community as a whole," said Theranica's chief executive officer and cofounder Alon Ironi. "Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population. As a result, Nerivio is now widely available as a drug-free alternative to treat migraine. Teens are one of the most vulnerable migraine populations and we are happy to provide them with a user-friendly tool to get them back to their daily lives as quickly as possible."