The FDA has granted expanded approval for the Nerivio remote electrical neuromodulation (REN) wearable, making it available for the acute treatment of migraines in children aged 8 years and older. This decision marks a significant advancement in pediatric migraine care, providing a non-pharmacological option for a condition that affects 1 in 10 children worldwide.
Clinical Evidence Supports Expanded Use
The FDA's approval was based on a study published in the Annals of the Child Neurology Society, which evaluated the safety and efficacy of REN in children aged 6 to 11 years. The study included 293 children (73.7% girls) with a median age of 11 years. Across 5493 REN treatments, significant benefits were observed. Specifically, 72.2% of patients reported pain relief, 36% reported pain freedom, 83.3% reported functional disability relief, and 38.9% reported functional disability freedom. Furthermore, migraine-associated symptoms disappeared in at least 50% of REN treatments for nausea/vomiting (70%), phonophobia (50%), and photophobia (22.2%).
Impact on Pediatric Migraine Treatment
"The age expansion indication cleared by the FDA dramatically improves the treatment landscape for children and adolescents," said Daniel Lax, MD, a pediatric neurologist and headache specialist with Montefiore Medical Center and assistant professor of neurology and pediatrics at Albert Einstein College of Medicine. He emphasized that many prescription medications used for migraine treatment were not originally developed or evaluated for children and adolescents, and some come with poor tolerability and disruptive side effects. "With the high safety and efficacy of the REN wearable, this FDA decision should open the door for considering this therapy as a first-line treatment for children and adolescents," Lax added.
Nerivio REN: A Non-Pharmacological Option
Nerivio REN is a wearable device that utilizes remote electrical neuromodulation to treat migraines. The device is now the first FDA-cleared, non-drug therapy for acute migraine treatment in children and the only prescribed preventive treatment of migraine for children in the 8-year or older age group. The study authors noted that REN was used as a standalone treatment, with over-the-counter medications, and with prescribed headache medications in 45.4%, 34.4%, and 20.9% of treatments, respectively, highlighting its versatility in managing migraine in children.
