FDA OKs Wearable Device for Migraine Pain
Posted on July 07, 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.