The U.S. Food and Drug Administration (FDA) has broadened the approved age range for Nerivio, a remote electrical neuromodulation (REN) wearable device, making it available for migraine treatment in children aged 8 years and older. This decision marks a significant advancement in pediatric migraine care, providing a novel, non-pharmacological option for a vulnerable patient population.
This approval represents the first FDA-cleared, non-drug therapy for the acute treatment of migraine in children and the only prescribed preventive treatment of migraine for children in this age bracket. The expanded indication addresses a critical gap in available treatments, particularly for those who may not tolerate or respond well to traditional medications.
The FDA's decision was supported by real-world data demonstrating the safety and efficacy of REN for migraine treatment in children aged 6 to 11 years. The data indicated that, two hours post-treatment, participants reported significant relief from pain and functional disability, without any reported adverse events. This evidence underscores the potential of Nerivio as a well-tolerated and effective therapeutic option.
Expert Commentary
Alon Ironi, CEO and cofounder of Theranica, the company behind Nerivio, stated that options for treating migraine in children under 12 have been limited, especially those that are safe, drug-free, and can be used for both acute and preventive treatment. He added that the expanded age indication offers a much-needed solution for children, especially those who are struggling with side effects from the traditionally prescribed drugs that were not designed nor formally indicated for young patients.
About Nerivio
Nerivio is a remote electrical neuromodulation (REN) device worn on the upper arm. It is designed to provide acute and preventive treatment for migraine by stimulating nerve pathways to interrupt pain signals. The device is controlled via a smartphone app, allowing for personalized treatment and data tracking.
Clinical Implications
The expanded approval of Nerivio offers a valuable new tool for healthcare providers managing pediatric migraine. With its non-pharmacological approach and demonstrated safety profile, Nerivio presents a promising alternative or adjunct to traditional migraine medications, potentially improving the quality of life for young patients and their families.
