Device becomes the first and only remote electrical neuromodulation wearable for migraine treatment for children 8 years and older<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“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.”<\/p>\n
Expanded approval of Nerivio was granted to Theranica.<\/p>\n