FDA approves Israeli migraine-relief patch for adolescents

The device will be used to soothe episodic and chronic migraines among adolescents who are 12 years and older.

By Jerusalem Post Staff, January 26, 2021

https://www.jpost.com/health-science/fda-approves-israeli-migraine-relief-patch-for-adolescents-656774

Girl with a headache (photo credit: INGIMAGE)

Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, announced on Monday that its Nerivio therapeutic device has received approval from the Food and Drug Administration.

The device will be used to soothe episodic and chronic migraines among adolescents who are 12 years and older, and is supported by a study recently published in Headache.

The Nerivio device

Some 37% of school-age children find that they do poorly in school due to headaches, which also negatively impact their social lives, according to a statement from Theranica.

The device is worn on the arm for 45 minutes, and uses Remote Electrical Neuromodulation (REN) to activate the brain to treat pain and migraine symptoms.

The device is worn on the arm

Some 71% of the adolescent participants using Nerivio experienced pain relief after two hours while 35% experienced complete liberation from pain, according to the Headache study. In addition, some 90% of the participants reported that the pain relief or complete freedom lasted for 24 hours. No harmful side effects were reported in the study.

“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” said Theranica’s CEO and co-founder Alon Ironi.

the Nerivio phone app.

“Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population," he said. "As a result, Nerivio is now widely available as a drug-free alternative to treat migraine.

"Teens are one of the most vulnerable migraine populations and we are happy to provide them with a user-friendly tool to get them back to their daily lives as quickly as possible."