Wearable Neurostimulation Device Receives Second Chronic Pain Breakthrough Designation From FDA
The FDA gave Quell (NeuroMetrix), a wearable neurostimulation device, a breakthrough designation for reducing moderate to severe chemotherapy-induced peripheral neuropathy (CIPN) that persists for six months or more after the end of chemotherapy.
Approximately 30% of chemotherapy patients experience chronic CIPN, defined as symptoms lasting longer than three to six months after the last chemotherapy treatment. There are no FDA-approved treatments for CIPN.
Quell is a noninvasive, wearable neuromodulator that uses position and motion sensing to automatically adjust stimulation. The device supports Bluetooth low energy to communicate with smartphone and smartwatch apps that allow the patient to personalize and control their treatment. Quell received a breakthrough designation for fibromyalgia in July 2021. It was originally approved in 2015, and a smartphone-controlled version was approved by the FDA in 2016.
The agency’s Breakthrough Device Program provides priority review and interactive communication from device development through to commercialization, to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis.
The data submitted by NeuroMetrix in support of the breakthrough designation included results from a six-week, open-label safety and efficacy study (N=29) of Quell used at home for treatment of patients diagnosed with CIPN. Study participants had completed chemotherapy with a neurotoxic agent at least three months earlier; had a clinical diagnosis of CIPN; and reported lower-extremity symptoms of pain, tingling, numbness or cramping. Change in score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–CIPN 20-item scale (EORTC-CIPN20), a composite measure of CIPN symptoms and functional impairments, was the study’s primary outcome measure.
There were statistically significant group improvements in the EORTC-CIPN20 and other outcome measures, with the relative improvements ranging from 13% to 52%. All adverse effects with use of the device were mild and self-limiting.
A National Cancer Institute–funded, multicenter, randomized, double-blind, sham-controlled trial of Quell in CIPN is expected to be completed by the end of 2022.
Source: PainMedicsNews
