FRIDAY, Nov. 22, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has expanded the age indication for Nerivio, making it the first and only remote electrical neuromodulation (REN) wearable for migraine treatment for children aged 8 years and older.
The approval marks the first FDA-cleared, nondrug therapy for acute treatment of migraine in children and the only prescribed preventive treatment of migraine for children in this age group.
The approval is based on real-world data showing the safety and efficacy of REN for migraine treatment in children aged 6 to 11 years. Two hours posttreatment, participants reported significant pain relief and functional disability relief, with no adverse events.
"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," Alon Ironi, CEO and cofounder of Theranica, said in a statement. "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."
Expanded approval of Nerivio was granted to Theranica.
More Information
