FDA okays NeuroMetrix's Quell for fibromyalgia

NeuroMetrix announced Thursday that its Quell wearable neuromodulation device received FDA de novo authorisation as the first non-pharmacological treatment for fibromyalgia. Quell Fibromyalgia, which was granted an FDA breakthrough designation last year, is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity.

"Our initial commercialisation efforts will focus on rheumatologists and pain medicine physicians," said CEO Shai Gozani, adding "we anticipate launching in the fourth quarter, with initial prescriptions processed by an online pharmacy partner before the end of this year."

The FDA submission included data from a trial comparing three months of at-home treatment with Quell to a sham device in 119 subjects. Researchers said the study, published in the Journal of Pain Research, missed its primary endpoint, showing "modest treatment effects" of reduced disease impact, pain and functional impairment from wearable TENS, although those with higher pain sensitivity exhibited greater benefit than those with lower pain sensitivity. In a pre-specified subgroup analysis of 60 participants with high pain sensitivity, NeuroMetrix noted that Patient Global Impression of Change (PGIC) scores were 1.25 points higher in the active arm than the sham arm.

For secondary outcomes, NeuroMetrix said participants receiving treatment reported significant improvements in 19 of 21 symptoms comprising the Fibromyalgia Impact Questionnaire (FIQR), including pain, sleep, fatigue, balance and the ability to carry out typical daily activities.

Quell was launched in 2015, with NeuroMetrix at the time calling it the "only FDA-cleared wearable for 24/7 chronic pain relief." The company also says Quell is "the only wearable neurostimulator that is enabled by proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card." The device uses position and motion sensing to automatically adjust stimulation, and supports Bluetooth low energy to communicate with mobile apps for multiple smartphone and smartwatch platforms.

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