Noctrix Health announced that the U.S. Food and Drug Administration (FDA) has granted its De Novo request for the NTX100 Tonic Motor Activation (TOMAC) System to treat symptoms of moderate-severe RLS and improve sleep quality in patients refractory to medications. The FDA had previously granted a "Breakthrough Device Designation" for this 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 FDA grant comes on the heels of successful completion of the 133 patient, multi-center, randomized, sham-controlled study (The RESTFUL Study NCT04874155) 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. This decision from the FDA makes the NTX100 TOMAC System the first and only therapy for patients with moderate-severe, drug-refractory RLS, one of the hardest to treat populations without any approved drug or device alternatives.
"It is particularly impressive that use of this therapy resulted in enduring and clinically significant improvements in RLS symptom severity and sleep quality in a population of patients that suffer from severe RLS despite being on standard of care medications. The safety profile of this device only adds to its value proposition," said Richard Bogan, MD, Principal Investigator for the RESTFUL Study and the Clinical Associate Professor at University of South Carolina School of Medicine and Principal at Bogan Sleep Consultants, LLC.
"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," said Asim Roy, MD, one of the Principal Investigators for the RESTFUL Study and the Medical Director of the Ohio Sleep Medicine Institute.
"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," said Mark Buchfuhrer, MD, Clinical Associate Professor at Stanford University School of Medicine.
"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 thank the FDA for recognizing the large unmet need and working with us from granting the Breakthrough Device Designation through final authorization. We look forward to bringing this therapy to market expeditiously. We are very grateful for the effort and enthusiasm shared by our clinical investigators, which was the key to successful completion of this large RCT," said Shri Raghunathan, President and Chief Executive Officer of Noctrix Health.
