Children with Migraine Can Now Receive Neuromodulatory Treatment with the Nerivio REN Device

The Food and Drug Administration (FDA) has expanded the age indication for Nerivio (Theranica, Bridgewater Township, NJ), making it the first non-drug therapy and prescribed preventive treatment for children with migraine aged ≥8 years. Nerivio is a remote electrical neuromodulation (REN) device worn on the arm that is self-administered via smartphone to activate the conditioned pain modulation (CPM) pathway to reduce symptoms of migraine. According to a statement from Theranica, the expansion of Nerivio’s indication addresses a critical need for preventing long-term disability, disease progression, and quality of life impacts associated with migraine in children and adolescents.

The approval follows data published in the Annals of the Child Neurology Society from a real-world analysis observational study (NCT06138756) assessing the safety and efficacy of Nerivio for the acute treatment of 293 children with migraine aged 6 to 11 years (median age: 11 years). Efficacy was evaluated based on voluntary participant-reported data.

• 72.2% of participants (13 of 18) reported pain relief with REN treatment.
• 36.0% (9 of 25) reported pain freedom.
• 83.3% (15 of 18) reported functional disability relief.
• 38.9% (7 of 18) reported functional disability freedom.

Overall, 63.6% of participants (7 of 11) reported freedom from ≥1 symptom of migraine in ≥50% of REN treatments.

• 70.0% (7 of 10) reported freedom from nausea/vomiting.
• 50.0% (4 of 8) reported freedom from phonophobia.
• 22.2% (2 of 9) reported freedom from photophobia.

Additionally, 64.7% of REN treatments were not followed by another treatment within 24 hours, implying a lack of migraine recurrence within that time period.

"For children and adolescents, uncontrolled migraine disease can negatively impact life trajectory and potentially lead to other disabilities. Early and effective intervention is critical, however more options for effective treatment are needed, specifically in patients younger than 12 years old," said Dr. Trevor Gerson, MD, Associate Professor of Pediatrics at the University of Missouri–Kansas City School of Medicine and Associate Program Director of the Headache Medicine Fellowship. "This FDA approval allows medical professionals (not just headache specialists) to offer the REN device so even more patients have access to an effective treatment option that is safe and not limited by how often it may be used."