FDA grants de novo status to restless legs syndrome therapy

Key takeaways:

• The FDA granted de novo status to the NTX100 Tonic Motor Activation System for patients with moderate to severe, drug-refractory RLS.
• The decision was based on positive data from a randomized controlled trial.

The FDA has granted Noctrix Health its de novo request for the NTX100 Tonic Motor Activation System, the first therapy for patients with moderate to severe, drug-refractory restless legs syndrome, according to a company press release.

The approval was based on positive data from the RESTFUL study, a multicenter, randomized sham-controlled trial of 133 patients with restless legs syndrome (RLS). According to the release, the NTX100 Tonic Motor Activation (TOMAC) System met all efficacy outcomes and was well-tolerated with no significant adverse events.

The system, which was granted breakthrough device designation by the FDA in May 2020, is a prescription therapy that includes a pair of wearable devices that bilaterally activate the peroneal nerves in the lower legs. This activation elicits “tonic, sustained muscle activation that is compatible with sleep to suppress symptoms of RLS,” the company stated.

“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 medication,” Richard Bogan, MD, principal investigator of the study, clinical associate professor at University of South Carolina School of Medicine and principal at Bogan Sleep Consultants, said in the release. “The safety profile of this device only adds to its value proposition.”

Shri Raghunathan, president and CEO of Noctrix Health, added: “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 randomized controlled trial.”

The FDA explains on its website that de novo approval “provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”

Reference:

• FDA. De novo classification request. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request#:~:text=The%20De%20Novo%20request%20provides,no%20legally%20marketed%20predicate%20device. Updated Oct. 4, 2022. Accessed April 24, 2023.