The U.S. Food and Drug Administration (FDA) has approved Neurolief Inc.’s Proliv Rx, the first prescription, physician-directed, at-home brain neuromodulation therapy for adults suffering from depression who have not experienced adequate improvement from at least one prior antidepressant medication.

The approval under the Class III Premarket Approval (PMA) pathway was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating Proliv Rx in Major Depressive Disorder (MDD) with inadequate response to antidepressant medications.

“The Proliv Rx pivotal study results represent an important new option for patients who have not responded adequately to medications,” said Mark S. George, MD, a principal investigator of the MOOD clinical trial and professor of Psychiatry and Neurology at the Medical University of South Carolina (MUSC). “This accessible therapy with a favorable safety profile addresses a significant unmet need in this underserved patient population and expands how we can deliver care.”

This approval gives clinicians and health systems scalable next-step therapy when medications fail, enabling clinically validated brain neuromodulation to be delivered at home under physician oversight, without the access constraints, infrastructure, or operational burden of clinic-based interventions.

“Until now, patients struggling with difficult-to-treat depression did not have a non-pharmacological therapy option that could be administered at home”, said Linda Carpenter, M.D., principal investigator of the MOOD clinical trial, professor of Psychiatry at Brown University, and director of the Neuromodulation Program at Butler Hospital. “Even though there is a tremendous need for new treatment approaches when antidepressant medications aren’t working, access to interventional psychiatry services like Transcranial Magnetic Stimulation (TMS) remains limited. Now we can offer our patients Proliv Rx therapy with continued medical supervision and the convenience of home use. Not only does Proliv Rx introduce a novel mechanism for noninvasive neuromodulation through its actions on the occipital and trigeminal neural pathways, but it also establishes a new treatment paradigm by making evidence-based neuromodulation widely accessible, beyond the walls of the specialty clinic”. 

Proliv Rx is reportedly the first therapy to deliver focal, multi-channel, external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) therapy. It applies gentle electrical pulses to targeted neural pathways associated with depression, without invasive procedures and with low risk of systemic side effects.

Neurolief expects Proliv Rx to be available in the United States early this year through authorized prescribers, with initial deployment focused on health systems, behavioral health programs, and integrated care settings seeking scalable solutions for patients who have not adequately responded to antidepressant therapy.

“Proliv Rx was developed to extend brain neuromodulation beyond the limitations of traditional clinic-based care,” Neurolief CEO Scott Drees stated. “Patients who don’t respond adequately to antidepressants face practical barriers to accessing clinic-based therapy. We are excited to make this therapy available to physicians and their patients.”

Neurolief is a neuromodulation company pioneering a new generation of physician-directed therapies for neuropsychiatric and neurological disorders. The company has developed a non-invasive, multi-channel brain neuromodulation platform designed for use in the home and in clinic, enabling targeted stimulation of key neural pathways involved in regulating mood and pain. Neurolief’s technology is FDA-cleared and CE-marked for migraine treatment.