FDA OKs Wearable Device for Migraine Pain

By Megan Brooks
WebMD Health News

May 29, 2019 -- The FDA has cleared a noninvasive device to relieve acute migraine pain.

Nerivio Migra is a "first-in-category product," according to Theranica, the company that makes it. It is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine pain.

The device is for the acute treatment of migraine with or without aura in adults who don't have chronic migraine.

The FDA approved the device on the basis of results of a randomized, double-blind, placebo-controlled study involving 252 patients who had two to eight migraines per month.

People in the study who used Nerivio Migra had much more pain relief than people using a placebo (66.7% vs. 38.8%). They also had more freedom from pain (37.4% vs. 18.4) and relief of most bothersome symptoms (46.3% vs. 22.2%) 2 hours after treatment.

The pain relief lasted 48 hours after treatment. The rate of device-related harmful events was low and was similar between treatment groups (4.8% vs. 2.4%). Device-related side effects included a sensation of warmth, temporary arm/hand numbness, redness, itching, tingling, muscle spasm, and pain in the arm, shoulders, or neck. All were mild and resolved within 24 hours. They did not require medical treatment.

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.

The company plans to launch Nerivio Migra in the United States 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."

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Sources: Headache: "Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial."

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