Benzinga | Jun 9, 2021 11:21AM EDT

NeuroMetrix's Nerve Stimulator Shows Mixed Outcomes In Fibromyalgia Trial

* NeuroMetrix Inc (NASDAQ:NURO) has reported that top-line results from a randomized controlled trial of Quell for fibromyalgia will be presented at two upcoming pain medicine conferences.

* Quell is a transcutaneous electrical nerve stimulator indicated for symptomatic relief and management of chronic lower extremity pain and is available over-the-counter.

* A total of 119 fibromyalgia subjects were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use.

* In the intention-to-treat population, the treatment difference in the Patient Global Impression of Change (PGIC, primary endpoint) was not significant. PGIC reflects a patient's belief about the efficacy of treatment.

* However, in a pre-specified subgroup analysis of subjects with elevated baseline pain sensitivity, the active treatment group exhibited significant and clinically meaningful improvements compared to sham.

* The PGIC responder rate was 58% (active) versus 30% (sham). The pain responder rate (over 30% reduction) was 58% (active) versus 18% (sham).

* The health-related quality of life assessment responder rate (over 15% reduction) was 56% for the active device compared to 35% for sham.

* There were few adverse events, and all were minor and self-limited.

* The use of Quell for fibromyalgia is investigational.

* Price Action: NURO shares are up 0.90% at $3.38 during the market session on the last check Wednesday.