The Food and Drug Administration (FDA) has cleared the NTX100 Tonic Motor Activation (TOMAC) System for the treatment of medication-refractory moderate to severe restless legs syndrome (RLS) to improve sleep quality.
The prescription therapy includes a noninvasive peripheral nerve stimulation device that is worn on the lower legs. The device suppresses RLS symptoms by activating the peroneal nerves bilaterally using high-frequency, low-level electrical stimulation to produce tonic, sustained muscle activation. Using the Clinician App, a prescriber can calibrate therapy output specific to the patient. The user-interface on the device allows patients to start or stop stimulation, adjust intensity, and read battery status.
The approval was based on data from the RESTFUL Study (ClinicalTrials.gov Identifier: NCT04874155), a randomized, sham-controlled trial that included 133 drug-resistant RLS patients. The primary endpoint of the study was responder rate, defined as the proportion of responses of “much improved” or “very much improved” relative to baseline on the investigator-rated 7-point Clinical Global Impressions-Improvement scale.
Findings showed that treatment with the NTX100 TOMAC System met the primary endpoint demonstrating statistically significant improvement in RLS symptoms compared with sham. The study also met all of its secondary endpoints, which measured RLS symptom severity and improvements in sleep quality. No significant adverse events were reported during the study.
“Having personally seen the benefits patients have experienced from this device as a Principal Investigator, I am very excited to see the impact this is going to have on millions of patients and practices across the nation,” said Asim Roy, MD, one of the Principal Investigators for the RESTFUL Study and the Medical Director of the Ohio Sleep Medicine Institute. “A clinically effective, nonpharmacologic therapy with minimal side effects is a game changer for this population.”
- Noctrix Health announces successful randomized controlled trial (RCT) outcomes and FDA marketing authorization for its breakthrough tonic motor activation (TOMAC) restless legs syndrome (RLS) therapy. News release. Noctrix Health. Accessed April 20, 2023. https://www.prnewswire.com/news-releases/noctrix-health-announces-successful-randomized-controlled-trial-rct-outcomes-and-fda-marketing-authorization-for-its-breakthrough-tonic-motor-activation-tomac–restless-legs-syndrome-rls-therapy-301802232.html.
- US Food and Drug Administration. FDA Roundup: April 18, 2023. Accessed April 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-18-2023.