The US Food and Drug Administration (FDA) has granted Noctrix Health its De Novo request for the NTX100 Tonic Motor Activation System to treat symptoms of moderate to severe restless legs syndrome (RLS) and improve sleep quality in patients refractory to medications.
The FDA previously granted a Breakthrough Device Designation for the therapy in May 2020. The prescription therapy includes a pair of devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation that is compatible with sleep to suppress symptoms of RLS.
“The De Novo grant represents an important milestone in our journey to deliver a truly impactful alternative to millions of patients that do not respond to RLS medications … We look forward to bringing this therapy to market expeditiously,” says Shri Raghunathan, PhD, president and CEO of Noctrix Health, in a release.
The FDA grant comes on the heels of the completion of a 133-patient, multi-center, randomized, sham-controlled study (The RESTFUL Study) in which all seven efficacy outcomes met statistical significance. The therapy was well-tolerated by patients and did not result in any significant adverse events.
“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. A clinically effective, non-pharmacologic therapy with minimal side effects is a game-changer for this population,” says Asim Roy, MD, one of the principal investigators for the RESTFUL Study and the medical director of the Ohio Sleep Medicine Institute, in a release.
Mark Buchfuhrer, MD, clinical associate professor at Stanford University School of Medicine, says in a press release, “As someone that has treated thousands of RLS patients, authored many of the clinical guidelines and multiple books and articles on managing RLS, I see tremendous potential in having this new therapy in our clinical arsenal. Use of this device could prevent the need for up-titration of dopaminergic agonists in patients with worsening symptoms caused by dopamine drug-induced augmentation.”
Photo caption: NTX100 Tonic Motor Activation System
Photo credit: Noctrix Health