The FDA has granted De Novo authorization for NeuroMetrix to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity, according to a company press release.
“There is an unmet need for effective and safe fibromyalgia treatments,” Shai N. GozanMD, PhD, CEO of NeuroMetrix, said in the release. “Receiving this De Novo authorization is a key milestone towards the company goal of making Quell available as a prescription treatment option for people living with fibromyalgia.
“We believe physicians treating patients with fibromyalgia will be interested in Quell’s potential clinical benefits and safety profile,” Gozani added. “Our initial commercialization efforts will focus on rheumatologists and pain medicine physicians. We anticipate launching in the fourth quarter, with initial prescriptions processed by an online pharmacy partner before the end of this year. ”
According to NeuroMetrix, a medical equipment manufacturing firm based in Woburn, Massachusetts, the company received FDA breakthrough designation for the use of Quell to treat fibromyalgia in July 2021.
Quell is a wearable, non-invasive, transcutaneous electrical nerve stimulation device in a “form factor the size of a credit card,” the company said. The device may be worn during sleep and uses position and motion sensing to automatically adjust stimulation. It is currently indicated for the treatment of fibromyalgia symptoms and chronic lower extremity pain in adults with high pain sensitivity.
Data submitted by NeuroMetrix in support of its De Novo request included results from a double-blind, randomized, sham-controlled trial of 119 patients with fibromyalgia. Participants were randomized to either an active or sham Quell device for 3 months of at-home use.
In a pre-specified subgroup analysis of 60 participants with high pain sensitivity – defined based on Quantitative Sensory Testing – Patient Global Impression of Change (PGIC) was 1.25 (95% CI, 0.25-2.24) points higher in the active arm, compared with the sham arm (P = .015). According to the company, PGIC, the primary study outcome, represents a participant’s overall belief about the efficacy of treatment on a seven-point categorical scale.
In addition, the intention-to-treat analysis of all 119 randomized participants produced multiple 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 with 34% among the sham arm (P = .014).
Participants in the active arm also reported statistically significant improvements in 19 of the 21 symptoms comprising the FIQR instrument, including pain, sleep, fatigue, balance and the ability to perform typical daily activities. Some of the trial results were published in the Journal of Pain Research.
The company reported a total of nine adverse events deemed to be definitely or possibly related to device use – 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 occurrence was a rash under the Quell electrodes.