Theranica’s Nerivio OK’ed for Preventive Migraine Treatment

Theranica, a digital therapeutics company developing neuromodulation devices for migraine and other pain conditions, has received U.S. Food and Drug Administration (FDA) clearance for its Nerivio prescription wearable as a dual-use acute and preventive treatment for migraine with or without aura in people 12 and older.
 
In a study, the drug-free Nerivio used every other day showed “significant reduction” in monthly migraine days and other prevention endpoints. Nerivio previously gained clearance and an acute treatment for migraine in the same patient population.
 
For some people, prescription drugs for migraine can be poorly tolerated or not effective. Further, if consumed too frequently some drugs can lead to medication overuse headache.
 
The Nerivio physician-prescribed treatment is discreet and non-disruptive. It’s controlled with a smartphone and self-administered, wrapping around the upper arm and using non-painful remote electrical modulation (REN) to activate peripheral nerves and induce internal pain management mechanism called conditioned pain modulation (CPM) in remote body region.
 
Each treatment lasts 45 minutes and recommended to use every other day for prevention, or at the start of a migraine attack for acute treatment. The new dual-use indication means the wearable can be used more frequently to proactively prevent migraines.
 
“Nerivio was purposely built to meet the real-life needs of people living with migraine,” Theranica CEO and co-founder Alon Ironi told the press. “While there is an established desire for effective non-drug options, especially for adolescents, migraine care needs to treat the whole person given the nature of this long-term disease. With this in mind, we developed an innovative wearable with a personalized wraparound care plan. Nerivio is paving a bold path forward in migraine treatment and prevention for adolescents and adults. We are hopeful this expanded dual-use indication will have a tremendous impact on mitigating the burden of migraine symptoms and improving patient quality of life.”
 
Beyond the wearable, the Nerivio app allows users to customize their migraine treatments, receive reminders for preventive treatments, track their migraine patterns, and optionally share migraine data with their doctor. The application also leads users through a Guided Intervention of Education and Relaxation (GIER), utilizing techniques such as diaphragmatic breathing, muscle relaxation, and guided imagery.