FDA Grants Marketing Approval for Neuromodulation Device to Reduce Symptoms of Fibromyalgia

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The FDA has granted De Novo clearance for NeuroMetrix to market its Quell neuromodulation device as an aid in reducing symptoms of fibromyalgia in adults with elevated pain sensitivity, according to a company press release.

“There is an unmet need for effective and safe treatments for fibromyalgia,” Shai N. GozaniMD, PhD, CEO of NeuroMetrix, said in the release. “Receiving this De Novo clearance is a key step towards the company’s goal of making Quell available as a prescription treatment option for people with fibromyalgia.


US Food and Drug Administration
The FDA has granted De Novo clearance for NeuroMetrix to market its Quell neuromodulation device as an aid in reducing symptoms of fibromyalgia in adults with elevated pain sensitivity, according to a company press release. Source: Adobe Stock.

“We believe physicians treating patients with fibromyalgia will be interested in the potential clinical benefits and safety profile of Quell,” Gozani added. “Our initial commercialization efforts will focus on rheumatologists and pain physicians. We expect a Q4 launch, with initial prescriptions processed through an online pharmacy partner before the end of this year. »

According to NeuroMetrix, a medical device manufacturing company based in Woburn, Massachusetts, the company received breakthrough designation from the FDA for the use of Quell to treat fibromyalgia in July 2021.

Quell is a portable, noninvasive, transcutaneous electrical nerve stimulation device in a “credit card-sized form factor,” the company said. The device can be worn while sleeping and uses position and motion sensing to automatically adjust stimulation. It is currently indicated for the treatment of symptoms of fibromyalgia and chronic lower extremity pain in adults with high pain sensitivity.

Data submitted by NeuroMetrix in support of its De Novo application included results from a double-blind, randomized, simulation-controlled trial of 119 patients with fibromyalgia. Participants were randomized to receive an active or sham Quell device for 3 months of home use.

In a pre-specified subgroup analysis of 60 participants with elevated pain sensitivity – defined on the basis of quantitative sensory testing – the patient’s global impression of change (PGIC) was 1.25 (95% CI %, 0.25 to 2.24) higher points in the working arm, compared to the false arm (P = 0.015). According to the company, the PGIC, the primary outcome of the study, represents a participant’s overall belief in the effectiveness of the treatment on a seven-point categorical scale.

Additionally, the intention-to-treat analysis of the 119 randomized participants yielded several positive secondary outcome measures. According to the company, 57% of those on active treatment demonstrated a clinically meaningful improvement in health-related quality of life – based on the Fibromyalgia Impact Questionnaire (FIQR) – compared to 34% in the sham group. (P = 0.014).

Participants in the active group also reported statistically significant improvements in 19 of the 21 symptoms making up the FIQR instrument, including pain, sleep, fatigue, balance, and the ability to perform typical daily activities. Some of the trial results have been published in the journal of pain research.

The company reported a total of nine adverse events deemed definitely or possibly related to use of the device – four in the active arm and five in the sham arm – during the study. All events were minor and self-limited, the company said. The most common event was a rash under the Quell electrodes.

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