Noctrix Health announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications.
RLS is the second most common sleep disorder in the world and impacts over 10% of the adult population in the US, with an estimated 3 million cases each year and is mainly treated using dopaminergic drugs. Patients report painful sensations of tingling and an urge to move their feet which particularly worsens during evenings and nights. “Today, an estimated third of all RLS patients remain refractory or continue to have severe symptoms despite being on medications for years and that doesn’t even include the millions that cannot tolerate medication side-effects and would like an alternative,” said Allan May, member of Noctrix Health’s board of directors. Drugs, particularly dopaminergic ones, pose a high risk of “augmentation” of the condition especially with higher doses that are often required to treat moderate-severe RLS symptoms. Noctrix Health aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers in a manner that is comfortable to wear to sleep.
The FDA Breakthrough Devices Program is a two-phase process intended to help patients receive timely access to breakthrough technologies that provide more effective treatment than the current standard of care for a life-threatening, or irreversibly debilitating disease. The treatment needs to have shown promising early clinical evidence that demonstrate an improvement over standard of care in order to be eligible for this designation. Shri Raghunathan, President & CEO of Noctrix Health, said: “We are thrilled that the FDA recognizes the promising potential that the therapy provides to millions of patients and very much look forward to working together with the agency during Phase 2 of this process to make this therapy available to patients expeditiously.”