NeuroMetrix: Quell Device Gets FDA OK as 1st Non-Pharmacological Treatment for Fibromyalgia

 NeuroMetrix, Inc. (Nasdaq: NURO) today announced U.S. Food and Drug Administration (FDA) De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Company received FDA Breakthrough Designation for the use of Quell to treat fibromyalgia in July 2021.

Fibromyalgia is a chronic condition characterized by generalized pain, fatigue, poor sleep, memory and concentration impairments, mood disorders and other disabling symptoms. These individuals experience low health-related quality of life and are twice as likely to be hospitalized as someone without fibromyalgia. The prevalence of fibromyalgia is estimated to be 2 to 6 percent of the U.S. adult population (5 to 15 million people). The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the central nervous system processes normal sensations and pain. Although a number of drugs are used to treat fibromyalgia only pregabalin, duloxetine and milnacipran have been approved by the FDA. These drugs are associated with side effects and generally poor adherence. Prior to Quell, the FDA had not approved or cleared any medical devices for treatment of fibromyalgia.

The data submitted by NeuroMetrix in support of the De Novo request included results from a double-blind, randomized, sham-controlled trial (NCT03714425). A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use. In a pre-specified subgroup analysis of subjects with high pain sensitivity (N=60), Patient Global Impression of Change (PGIC) was 1.25 (95% CI [0.25, 2.24]) points higher in the active arm compared to the sham arm (p=0.015). PGIC was the primary study outcome measure and represents a subject’s overall belief about the efficacy of treatment on a 7-point categorical scale. The high pain sensitivity subgroup was defined based on Quantitative Sensory Testing and should represent the majority of fibromyalgia patients in real-world practice.

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