Quell received the authorization as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell garnered FDA breakthrough device designation to treat fibromyalgia in July 2021.
Much like when it received the breakthrough nod, NeuroMetrix’s stock is on the rise today, with shares currently up 38% at $4.31 per share in early-morning trading.
Data supporting the de novo request for Quell came from a double-blind, randomized, sham-controlled trial of 119 subjects with fibromyalgia. The subjects were randomized to a standard (active) or modified (sham) Quell device for three months of at-home use.
For 60 subjects with high pain sensitivity, Patient Global Impression of Change (PGIC), which stood as the primary study outcome measure as a representation of a subject’s overall belief about the efficacy of treatment on a seven-point categorical scale, was 1.25 points higher in the active arm compared to the sham arm.
Among all randomized subjects, 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality of life, compared to 34% who received the sham treatment. Subjects in the active treatment arm reported statistically significant improvements in 19 of the 21 symptoms comprising the Fibromyalgia Impact Questionnaire (FIQR) instrument, including pain, sleep, fatigue, balance and the ability to carry out typical daily activities.
Nine adverse events were reported during the study, with all deemed to be definitely or possibly related to device use. Four events were reported in the active arm and five in the sham arm, with all events minor and self-limited. The most common occurrence was a rash under the Quell electrodes.
“There is an unmet need for effective and safe fibromyalgia treatments. Receiving this de novo authorization is a key milestone towards the Company’s goal of making Quell available as a prescription treatment option for people living with fibromyalgia,” NeuroMetrix CEO Dr. Shai N. Gozani said in a news release. “We believe physicians treating patients with fibromyalgia will be interested in Quell’s potential clinical benefits and safety profile.
“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.”