Noctrix Health Inc’s wearable TOMAC therapy for the treatment of restless legs syndrome (RLS) was found to be safe and effective, providing a “substantial reduction” in symptoms, for adult patients with RLS refractory to medications, according to two studies published in Sleep.
The two papers feature the results from the RESTFUL study, a multicenter, randomized, sham-controlled clinical trial, and a subsequent 24-week extension study. The results come after the US Food and Drug Administration (FDA) granted the technology a Breakthrough Device Designation in May 2020 and subsequent market authorization in April 2023.
“The official publication of our clinical trial data in Sleep is an important milestone and an honor,” says Noctrix Health president and CEO Shri Raghunathan in a release. “We are grateful for the opportunity to highlight this work in a top-tier journal like Sleep to bring the impressive results of this research and the amazing work of our clinical investigators to the public. Our focus now is on executing our upcoming controlled release in the US and bringing the Nidra NTX100 therapy to the deserving patients who so desperately need it.”
The prescription therapy includes a pair of neuromodulation devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation, and suppress symptoms of RLS. The mechanism of action behind this therapy was also published earlier this month in the Journal of Clinical Sleep Medicine.
The RESTFUL study enrolled 133 adult participants with medication-refractory, moderate-to-severe primary RLS and reported statistical significance for all seven efficacy outcomes. The therapy was well-tolerated by patients and did not result in any significant adverse events. These data were taken into consideration by the FDA to grant a De Novo authorization, making the NTX100 TOMAC System the first and only therapy of its kind for patients with moderate-to-severe, drug-refractory RLS.
The extension study reinforced and further improved on these results to demonstrate that long-term use of TOMAC therapy provides robust and durable benefits at very low risk to patients. Mean responder rates and mean change in the International RLS Rating Scale improved from 63.6% and -7.4 points at eight weeks (end of RESTFUL randomized controlled trial) to 72.7% and -11.3 points at 24 weeks, respectively. Significant sleep quality improvements were also seen, as measured by a mean change of -17.2 points on the MOS-II sleep scale at 24 weeks from baseline.
Further to these results, patients on long-term TOMAC treatment experienced a 3.5-fold increase in symptom-free days per week, with the average frequency of RLS symptoms reducing from 5.9 to 3.2 days per week over the duration of use.
“As someone who has been at the forefront of clinical management of RLS for many years, I’m truly excited for our patients and clinicians alike when there are new options being studied and advanced through the regulatory and commercial processes. Publication of these results is an important milestone to including TOMAC therapy as an option to add to our arsenal,” says John Winkelman, MD, PhD, one of the authors of the RESTFUL study and chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital, in a release.
Ross Sylvia, Noctrix Health’s senior vice president of sales and marketing, adds in a release, “We are excited to embark on our controlled release of the Nidra™ NTX100 therapy in select states nationwide in the coming months. This well-planned deployment will enable us to effectively manage the introduction of this highly anticipated therapy. By adopting this approach, our primary goal is to acquire valuable insights, collect user feedback, and enhance our offerings, ensuring a seamless and optimal experience for both users and prescribers.”
Photo caption: Noctrix Health’s Nidra™ NTX100 therapy
Photo credit: Noctrix Health