FDA Approves Expanded Age Indication for Nerivio Migraine Device in Pediatric Patients

According to a new announcement, the FDA has approved an expanded age indication for Theranica's Nerivio remote electrical neuromodulation (REN) wearable to treat patients aged 8 years and older with acute migraine. With this expanded indication, the needle-free alternative treatment becomes the first cleared nondrug therapy for acute migraine treatment in pediatric patients and the only prescribed preventive migraine treatment in this patient age group.¹

This decision comes following a recently published study (NCT06138756) led by Klaus Werner, MD, PhD, a pediatric neurologist at Duke Health, which showed that treatment with the REN device was safe and effective for treating acute migraine in pediatric patients aged between 6 years and 11 years.^2,3 Published in the Annals of the Child Neurology Society, the study featured 293 patients with a median age of 11 years who used the REN device to treat at least 1 migraine attack. Of them, 18.4% reported at least 1 attack with aura, and the remaining 81.6% never reported aura. Notably, two-thirds (67.4%) of REN treatments were not followed by another REN treatment in 24 hours, indicating no retreatment and implying no recurrence in 24 hours.

“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,” Klaus Werner, MD, PhD, pediatric neurologist at Duke Health and associate professor of pediatrics at Duke University, recently told NeurologyLive^® in an interview. “I was very encouraged by the study findings and the experiences of my patients, many of whom I see every week. That encouragement led me to speak out and reach a broader community to share what is really happening—especially for those aged 8 years and older. It’s a very unique, new finding.”

In total, 5493 REN treatments were used in the study, with no adverse events (AEs) and no device-related AEs recorded among treated patients. Additional analyses assessing the number of device-related customer support inquiries revealed an average of 0.072 inquiries per child, which was similar to the inquiry rate of the entire population of REN users of all ages (0.067; P = .725).

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In terms of efficacy, results at 2 hours post-treatment showed that consistent efficacy in at least 50% of treatments was found in 72.2% (13 of 18) of patients for pain relief, 36.0% (9 of 25) for pain freedom, 83.3% (15 of 18) for functional disability relief, and 38.9% (7 of 18) for functional disability freedom. Consistent 2-hour post-treatment freedom from associated migraine symptoms was achieved in at least 50% of treatments per patient who reported a baseline symptom. Specifically, freedom rates were 70.0% (7 of 10) for nausea/vomiting, 50.0% (4 of 8) for phonophobia, and 22.2% (2 of 9) for photophobia. Overall, 63.6% (7 of 11) of patients reported freedom from at least one associated symptom.

Throughout the study, the use or avoidance of a rescue medication to treat headache pain was voluntarily reported in 304 treatments. Of these, REN was used as a standalone therapy in 45.4% (137 of 304) of treatments, while 34.4% (104 of 304) used a combination of REN and over-the-counter medications, and only 20.9% (63 of 304) used REN in combination with other prescribed medications. When using REN alone, without any rescue medication, nearly 3 of 4 (72.2%) children achieved relief from severe or moderate headaches, reducing them to mild or no headaches in at least 50% of their treatments.

In this population of younger patients, the average treatment intensity was 22.8% (±9.6%) of the max stimulator intensity, with a median of 20.5%. Overall, these statistics used in a real-world setting by children were similar yet slightly lower than what was measured in a previous study of adolescents (mean of 26.7 [±12.2]) and even lower than the average intensity used by an adult-based study (31.0 [±13.5]).

“For me, this is personally important. I started Theranica with my partners 8 years ago, largely motivated by seeing my own daughter suffer from migraine. It took far too long for her to be properly diagnosed, then even longer to receive meaningful medication, which came with horrible side effects,” Alon Ironi, CEO and cofounder at Theranica, told NeurologyLive. “So, 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—starting in the US, but we’re also active globally.”

REFERENCES
1. FDA Expands the Age Indication for Nerivio® as the First-and-Only REN Wearable for Migraine Treatment for Children Aged Eight and Above. News Release. Theranica. Published November 14, 2024. Accessed November 14, 2024.
2. New Study Evaluates Use of the Nerivio® REN Wearable for Treatment of Migraine in Children Under the Age of 12. News release. Theranica. July 25, 2024. Accessed November 12, 2024. https://www.prnewswire.com/news-releases/new-study-evaluates-use-of-the-nerivio-ren-wearable-for-treatment-of-migraine-in-children-under-the-age-of-12-302206102.html
3. Werner K, Gerson T, Stark-Inbar A, et al. Acute treatment of migraine in children aged 6-11: real-world analysis of remote electrical neuromodulation (REN). Annals of Child Neurology Soc. 2024;2(2):135-145. doi:10.1002/cns3/20073