Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older.
The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using Nerivio experienced pain relief after two hours while 35% experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90% of cases. Sixty-nine percent of the patients experienced improvement in their functional ability, defined by the ability to do schoolwork and perform “usual activities,” at two hours. There were no device-related serious adverse events.
“Having this drug-free migraine therapy available for the adolescent migraine community could positively impact patient compliance,” said study co-investigator Dr. Jennifer McVige, a headache and neuroimaging specialist at the DENT Neurologic Institute in Amherst, N.Y. “Teens do not always want to take pills, and some may be unable to do so due to various contraindications. Additionally, teens tend to easily adapt to tech. Nerivio is an efficacious smartphone-controlled tech solution that can be worn inconspicuously and is the perfect design for teens who may unfortunately begin to experience migraine attacks. As a mother of two teenagers with migraine, and someone who sees many adolescents in my practice, Nerivio is a promising new option with potential to help thousands of young patients.”
Nerivio is worn on the upper arm for 45 minutes and uses remote electrical neuromodulation to activate the brain’s native conditioned pain modulation mechanism to treat pain and associated migraine symptoms, according to a news release from Theranica. Nerivio was cited as one of TIME’s best inventions of 2019.
“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” said Theranica CEO Alon Ironi in the release. “Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population. 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.”
Nerivio is available by prescription. Every Nerivio unit is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new device.