NeuroMetrix De Novo Authorization for Fibromyalgia

FDA has granted NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity. The authorization was supported by data from a randomized, sham-controlled trial in 119 subjects with fibromyalgia. “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),” the company says. PGIC was the primary study outcome measure and represents a treated patient’s overall assessment of treatment efficacy on a seven-point categorical scale, it says. In an intent-to-treat analysis of all randomized subjects (N=119), 57% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life compared to 34% that received sham treatment.