Nerivio REN wearable now FDA-cleared to treat migraines in children 8 years and up
With this expanded FDA clearance, the wearable becomes the first FDA-cleared, non-drug therapy to treat acute migraines in children.
Nerivio REN wearable now FDA-cleared to treat migraines in children 8 years and up | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
According to a recent announcement from Theranica, the Nerivio remote electrical neuromodulation (REN) wearable for the acute treatment of migraines, has received an expanded age indication from the FDA for use in patients aged 8 years and older.1,2
With the expanded indication, Nerivio REN wearable becomes 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 the 8-year or older age group.1
"For children and adolescents, uncontrolled migraine disease can negatively impact life trajectory and potentially lead to other disabilities," said Trevor Gerson, MD, in a statement. Gerson is an associate professor of pediatrics with the University of Missouri-Kansas City School of Medicine and associate program director of the Headache Medicine Fellowship.1
"Early and effective intervention is critical, however more options for effective treatment are needed, specifically in patients younger than 12 years old," said Gerson. "This FDA [clearance] 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."1
Worldwide, migraine affects 1 in 10 children. Those living with migraine need acute and often preventive treatment, notably children and adolescents, who are at risk of long-term disability and disease progression into adulthood if it is not diagnosed and treated early.1
According to Theranica, expanded approval was granted by the FDA based on a study published in the Annals of the Child Neurology Society. Data demonstrated safety and efficacy of REN for migraine treatment in children aged 6 to 11 years, with patients reporting pain and functional disability relief 2 hours post treatment with no adverse events.1
According to study results, there were 293 children (73.7% girls) in the study with a median age of 11 years (interquartile range = 9−11). In all, there were 5493 REN treatments.2
"Efficacy in at least 50% of REN treatments was calculated from all patients who voluntarily reported pain levels, symptoms, and/or disability at treatment onset and at 2 [hour] post-treatment," stated the study authors in the Annals of the Child Neurology Society publication.2
In all, 72.2% of patients reported pain relief, 36% reported pain freedom, 83.3% reported functional disability relief, and 38.9% reported functional disability freedom. Migraine-associated symptoms disappeared in least 50% of REN treatments in2:
- 70% of patients for nausea/vomiting
- 50% phonophobia
- 22.2% photophobia
- 63.6% reported freedom from at least 1 associated symptom
Authors of the study noted that REN was used as a standalone treatment, with over-the-counter medications, and with prescribed headache medications in 45.4%, 34.4%, and 20.9% of treatments, respectively.2
"The age expansion indication cleared by the FDA dramatically improves the treatment landscape for children and adolescents," 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, said in the press release.1
"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," said Lax.1
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. Theranica. Press release. November 14, 2024. Accessed November 15, 2024. https://finance.yahoo.com/news/fda-expands-age-indication-nerivio-140500072.html
2. 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). Ann Child Neurol. Soc, 2: 135-145. https://doi.org/10.1002/cns3.20073
