The approval comes following a study on the efficacy of the migraine device.
The U.S. Food and Drug Administration today announced Theranica’s therapeutic device, Nerivio, was cleared to market for an expanded indication for acute treatment of episodic or chronic migraine in patients at least 12 years old.
Nerivio is worn on the upper arm for 45 minutes and uses Remote Electrical Neuromodulation to activate the brain’s Conditioned Pain Modulation mechanism to treat pain and associated migraine symptoms.
“Having this drug-free migraine therapy available for the adolescent migraine community could positively impact patient compliance,” Jennifer McVige, M.D., a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at the DENT Neurologic Institute, said in a statement. “…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.”
The clearance comes following a study published in the journal Headache. Findings of the study demonstrated 71% of the adolescent participants using the device experienced pain relief after two hours while 35% were completely pain free. In 90% of the cases, pain relief and pain freedom were sustained for 24 hours. A majority of the patients (69%) experienced improvement in their functional ability, which meant they could do schoolwork and perform typical activities at two hours.
There were no adverse events related to use of the digital therapeutic.
Nerivio is available by prescription by any licensed healthcare provider and is good for 12 units before being recycled. Patients can then get the prescription refilled with a new device.
“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” Theranica’s CEO and co-founder Alon Ironi said.