FDA Okays Smartphone-Controlled Wearable for Migraine Pain

Megan Brooks


May 28, 2019

The US Food and Drug Administration (FDA) has cleared a noninvasive neuromodulation device (Nerivio Migra, Theranica) for the relief of acute migraine pain.

Nerivio Migra is a "first-in-category product," according to the company. It is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine through conditioned pain modulation — an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions.

The device is indicated for the acute treatment of migraine with or without aura in adults who do not have chronic migraine.

The FDA cleared Nerivio Migra on the basis of results of a prospective, randomized, double-blind, placebo-controlled study involving 252 patients who experienced two to eight migraines per month.

Active stimulation with Nerivio Migra was significantly more effective than sham stimulation in achieving pain relief (66.7% vs 38.8%; therapeutic gain of 27.9%; P < .0001), freedom from pain (37.4% vs 18.4%; P = .003), and relief of most bothersome symptoms (46.3% vs 22.2%; P = .0008) 2 hours post treatment.

The superiority of the active treatment regarding pain relief and freedom from pain was sustained 48 hours after treatment. The incidence of device-related adverse events was low and was similar between treatment groups (4.8% vs 2.4%; P = .499).

The results were reported online May 9 in Headache.

"The clinical data of this innovative therapeutic device is of very high quality. It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs," neuroscientist Messoud Ashina, MD, PhD, of the Danish Headache Center, who is president-elect of the International Headache Society, said in a news release from the manufacturer.

"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," added Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut, who was principal investigator of the study.

"The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at 2 and 48 hours after treatment," said Grosberg.

The company plans to launch Nerivio Migra in the United States later this year "at an affordable price," Alon Ironi, CEO and cofounder of Theranica, said in the release. "We have identified at least 7 different painful conditions that may be relieved by this noninvasive, drug-free technology after appropriate clinical development," he added.

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