FDA Expands the Age Indication for Nerivio® as the First-and-Only REN Wearable for Migraine Treatment for Children Aged Eight and Above

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Nov 14, 2024, 09:05 ET

Children aged eight and up now have a prescribed non-drug option to treat migraine early and potentially prevent long-term disability and disease progression, addressing a critical unmet need in pediatric migraine care.

BRIDGEWATER, N.J. and NETANYA, Israel, Nov. 14, 2024 /PRNewswire/ -- Theranica, a prescribed neuromodulation therapeutics company, today announced the Nerivio^® REN wearable received an expanded age indication from the FDA for use in patients aged eight and above, making it the first FDA-cleared, non-drug therapy for acute treatment of migraine in children, and the only prescribed preventive treatment of migraine for children in this age group (8+). This provides safe, effective migraine treatment for an underserved population and addresses a critical gap in pediatric migraine care.

The Nerivio® REN wearable is FDA-cleared for patients aged 8+. It is now the only preventive treatment and the first non-drug acute migraine treatment for this age group.

"We believe the FDA's clearance of the Nerivio REN wearable for children aged eight and up is a major turning point for families seeking effective, accessible treatment for pediatric migraine," said Alon Ironi, CEO and co-founder of Theranica. "The options for treating migraine in children under 12, especially ones that are safe, drug-free, and can be used for both acute and preventive treatment have been very limited until now. 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."

Migraine is a debilitating neurological disease that has no cure and affects one billion people worldwide, including one in 10 children. People living with migraine need acute and often also preventive treatment. This is especially critical for children and adolescents as they are at risk of long-term disability and disease progression into their adulthood, when migraine is not diagnosed and treated early.

Migraine can significantly disrupt childhood, hindering schooling, social activities, and sleep, leading to a significant reduction in quality-of-life.

"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 with 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."

The expanded age indication comes after a study published earlier this year in the Annals of the Child Neurology Society. Real-world data demonstrated the safety and efficacy of remote electrical neuromodulation (REN) for migraine treatment in children aged six to 11. Participants reported significant pain relief and functional disability relief, two hours post treatment, with no adverse events, making the REN wearable a valuable tool in managing this chronic disease.

"The age expansion indication cleared by the FDA dramatically improves the treatment landscape for children and adolescents," said Dr. 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. "Many of the 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."

To learn more about how the Nerivio REN wearable is transforming migraine care for children and to access prescription forms, visit nerivio.com.

About Nerivio

Controlled by a smartphone app and self-administered, the Nerivio REN wearable is a complete migraine care treatment that wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm. These fibers send signals that trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to unleash a natural process in the brain to abort or relieve migraine headaches and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.

About Theranica

Theranica is a neuromodulation therapeutics company dedicated to creating effective, safe, affordable, low-side-effect therapies for idiopathic pain conditions. The company's award-winning flagship wearable, Nerivio^®, is the first FDA-cleared prescribed migraine REN wearable for acute and/or preventive treatment of migraine. Nerivio has been used in more than 1 million migraine treatments in the U.S., including by adolescents and veterans. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Learn more by visiting our websites, theranica.com and nerivio.com, and following us on LinkedIn, X (formerly Twitter), Instagram, and Facebook.