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FDA clears novel smartphone-controlled migraine treatment device
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Theranica announced that the FDA has granted clearance to its novel smartphone-controlled migraine device that is intended for the acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
The company said clearance for Nerivio Migra came through the FDA’s de novo program and after a prospective, randomized, double-blind, placebo-controlled, multicenter study consisting of 252 patients and two-thirds reduction in pain relief within 2 hours. Theranica's website states the product "delivers patented waveform to C-fiber nerves, invoking descending analgesic mechanism in [the] brain stem."
“This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults,” Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut and the study’s lead principal investigator, said in a press release. “The results of [that] study demonstrate a high efficacy ratio for single as well as multiple attacks, both at 2 and 48 hours after treatment."
The press release also stated the product uses smartphone-controlled electronic pulses to create a conditioned pain modulation response.
Stephen Silberstein, MD, director of the Headache Center at the Jefferson University Hospital in Philadelphia, put Nerivio Migra’s development in historical context.
“Over the last 20 years, my colleagues and I have used triptans and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contraindicated or have nontolerable side effects. This new innovative FDA-authorized treatment is an important alternative to help our patients control this debilitating condition,” Silberstein said in the release.
Theranica’s CEO said in the release that the company is preparing to launch Nerivio Migra in the U.S. later this year.
Disclosures: Healio Primary Care could not confirm Grosberg’s relevant financial disclosures at the time of publication. Silberstein is a member of Theranica’s medical advisory board.