The Quell® neuromodulation device (NeuroMetrix) has received the Food and Drug Administration De Novo authorization for use as an aid in reducing the symptoms of fibromyalgia in adults with high pain sensitivity.
Quell is a transcutaneous electrical nerve stimulator (TENS) that is worn on the upper calf. The device delivers electrical stimulation to the user through a disposable electrode.
The authorization was based on data from a double-blind, randomized, sham-controlled trial (ClinicalTrials.gov Identifier: NCT03714425) that included 119 patients with fibromyalgia. Participants were randomly assigned to receive at-home treatment with an active (n=62) or sham (n=57) Quell device for 3 months.
The primary endpoint of the study was Patients’ Global Impression of Change (PGIC), measured on a 7 point scale depicting a patient’s rating of overall improvement.
Results showed that in the intent-to-treat population, no differences were observed between the groups on PGIC scores, however, in patients with high pain sensitivity (n=60), PGIC was 1.25 (95% CI, 0.25-2.24) points higher in the active arm compared with the sham arm (P =.015).
Additionally, a greater percentage of patients in the active treatment arm reported clinically meaningful improvement in health-related quality of life, as measured by the Fibromyalgia Impact Questionnaire (FIQR; secondary endpoint), compared with the sham group (57% vs 34%; P =.014). Statistically significant improvements were observed in 19 of the 21 symptoms included on the FIQR.
The most common adverse reaction reported with the device was rash under the Quell electrodes.
“We believe physicians treating patients with fibromyalgia will be interested in Quell’s potential clinical benefits and safety profile,” said Shai N. Gozani, MD, PhD, Chief Executive Officer, NeuroMetrix. “We anticipate launching in the fourth quarter, with initial prescriptions processed by an online pharmacy partner before the end of this year.”
The Quell device for fibromyalgia is restricted to prescription use. The product has also been cleared for over-the-counter use in the treatment of chronic pain.
- NeuroMetrix reports that Quell® wearable neuromodulation device has received FDA De Novo authorization as first non-pharmacological treatment for fibromyalgia. News release. May 19, 2022. https://www.globenewswire.com/news-release/2022/05/19/2447000/0/en/NeuroMetrix-Reports-that-Quell-Wearable-Neuromodulation-Device-has-Received-FDA-De-Novo-Authorization-as-First-Non-Pharmacological-Treatment-for-Fibromyalgia.html.
- Jamison RN, Edwards RR, Curran S, Wan L, Ross EL, Gilligan CJ, Gozani SN. Effects of wearable transcutaneous electrical nerve stimulation on fibromyalgia: a randomized controlled trial. J Pain Res. 2021;14:2265-2282. doi.org/10.2147/JPR.S316371.
This article originally appeared on MPR