FDA clears NeuroMetrix's wearable neuromodulator as first non-drug fibromyalgia treatment

Scientists still may not know the exact cause of fibromyalgia, but that hasn’t stopped them from developing treatments for the chronic pain associated with the condition.

For years, all of those therapeutics have been of the pharmacological variety, with three drugs approved by the FDA since 2007. Now, however, patients will have a drug-free alternative to treat their fibromyalgia, as the agency issued a de novo clearance for a wearable neuromodulation system from NeuroMetrix designed to ease chronic pain.

The Quell device is worn in a sleeve that wraps around the upper calf. Electrodes attached to the band stimulate the sensory nerves in the leg to trigger the body’s pain relief response, easing symptoms of fibromyalgia.

In a clinical study of the system, nearly 60% of those who underwent regular treatments for three months experienced clinically meaningful improvements in their quality of life, including significant improvements in 19 of the 21 criteria listed in the quality-of-life survey.

Nine minor adverse events that occurred during the study were found to be “definitely or possibly” related to the Quell device, with the most common being a skin rash that developed underneath the electrodes.

The system’s algorithms automatically manage the intensity of each therapy session, based on the time of day, the wearer’s body position and sleep patterns, the possibility of desensitization over time and even changes in the weather.

Patients can monitor and control their therapy through an app on their smartphone or Apple Watch, which wirelessly collect readings from the Quell device via Bluetooth transmission.

The system is meant to be used for at least three one-hour sessions every day, though patients can opt to undergo many more sessions than that: The device’s standard settings begin treatment every other hour. It can be used either while a patient is sleeping or up and about.

The Quell starter kit—which includes the neuromodulator, one wearable band, a charger and a month’s supply of electrodes—retails for just under $300 on NeuroMetrix’s website. Though the Quell device is rechargeable, each strip of electrodes is meant to be replaced every two weeks; a four-pack of replacements goes for $80.

With the FDA’s nod, the Massachusetts-based company plans to launch the system as a fibromyalgia treatment in the fourth quarter of this year, when an online pharmacy partner will immediately begin processing prescriptions for the device, CEO Shai Gozani, M.D., Ph.D., said in a statement. They’ll start by marketing the device to rheumatologists and pain medicine doctors.

The Quell device received an initial 510(k) clearance from the FDA in 2014, when it was indicated as an over-the-counter treatment for chronic pain—without a specific focus on fibromyalgia. NeuroMetrix snagged another agency nod two years later for an updated version of the system that could be controlled via smartphone.

It wasn’t until last year that the FDA acknowledged the technology’s potential as a fibromyalgia treatment, issuing a breakthrough device designation for that indication in July. It scored another breakthrough label earlier this year, for Quell’s potential to ease long-lasting symptoms of chemotherapy-induced peripheral neuropathy.