The FDA has approved an expanded age indication for Theranica's Nerivio remote electrical neuromodulation (REN) wearable, making it available for acute migraine treatment in patients aged 8 years and older. This decision marks Nerivio as the first cleared non-drug therapy for acute migraine treatment in pediatric patients and the only prescribed preventive migraine treatment in this age group. The approval is based on a recent study demonstrating the device's safety and efficacy in treating acute migraine in children aged 6 to 11.
Study Highlights Nerivio's Efficacy and Safety
The study, led by Klaus Werner, MD, PhD, a pediatric neurologist at Duke Health, involved 293 patients with a median age of 11 years. Participants used the REN device to treat at least one migraine attack. The results, published in the Annals of the Child Neurology Society, indicated that 72.2% of patients experienced consistent efficacy in at least 50% of treatments for pain relief. Furthermore, 83.3% reported consistent relief from functional disability. Notably, two-thirds (67.4%) of REN treatments were not followed by another REN treatment within 24 hours, suggesting no recurrence during that period.
Clinical Outcomes and Adverse Events
Across 5493 REN treatments, no adverse events (AEs) or device-related AEs were recorded. Additional analyses showed an average of 0.072 device-related customer support inquiries per child, similar to the rate observed in the entire population of Nerivio users of all ages (0.067; P = .725). In terms of associated migraine symptoms, at least 50% of treatments per patient resulted in freedom from symptoms, with rates of 70.0% for nausea/vomiting, 50.0% for phonophobia, and 22.2% for photophobia. Overall, 63.6% of patients reported freedom from at least one associated symptom.
Real-World Usage and Treatment Intensity
In approximately 45.4% of treatments, Nerivio was used as a standalone therapy, while 34.4% involved a combination of Nerivio and over-the-counter medications, and 20.9% included Nerivio with other prescribed medications. When used alone, nearly three of four (72.2%) children experienced relief from severe or moderate headaches, reducing them to mild or no headaches in at least 50% of their treatments. The average treatment intensity in this younger population was 22.8% (±9.6%) of the maximum stimulator intensity, with a median of 20.5%.
Expert Commentary
"This device, Nerivio, is a truly unique and novel treatment for migraine, especially now for children 8 years of age and above, recently approved by the FDA for both acute and preventative treatment," said Klaus Werner, MD, PhD. Alon Ironi, CEO and cofounder at Theranica, added, "For me, reaching this milestone of the FDA expanding the indication feels like a dream come true. Finally, I have the chance to make this therapy accessible to so many children."
