The approval comes following a study on the efficacy of the migraine device.
Photo via PR Newswire
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.
DC Roundtable: Patrick Cooney of The Federal Group Drops the Latest on PBM Legislation in Washington
April 11th 2024In this episode of "DC Roundtable," Peter Wehrwein, managing editor of Managed Healthcare Executive, spoke with Patrick Cooney, president of The Federal Group, a lobbying and strategic planning firm in Washington, D.C., about recent developments in Washington concerning PBMs.
Listen
2024 Emerging Leaders in Healthcare — Submit For a Chance to Be Featured in MHE's August Issue
April 24th 2024MHE Editors are seeking diverse healthcare professionals from different backgrounds and healthcare sectors, with individual interests. Eligible candidates are early or mid-career leaders with less than 10 years of experience. Award winners will enjoy complimentary passes to the PBMI Annual National Meeting in Orlando, Florida, from Sept. 4-6. Additional perks include a feature in our August issue, a subscription to MHE and more!
Read More