By Chris Wack

NeuroMetrix Inc. said the U.S. Food and Drug Administration gave De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity.

The company received FDA Breakthrough Designation for the use of Quell to treat fibromyalgia in July 2021.

The data submitted by NeuroMetrix in support of the De Novo request included results from a double-blind, randomized, sham-controlled trial. A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard or modified Quell device for 3-months of at-home use.

A total of 9 adverse events were reported during the study and deemed to be definitely or possibly related to device use, the company said. All events were minor and self-limited. The most common occurrence was a rash under the Quell electrodes.

NeuroMetrix shares were up 40% to $4.37 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 19, 2022 09:40 ET (13:40 GMT)