FDA Approves ProlivRX: First Prescription, Physician-Directed, At-Home Brain Neuromodulation Therapy for MDD

The US Food and Drug Administration (FDA) has approved Neurolief Inc’s ProlivRx, the first prescription, physician-directed, at-home brain neuromodulation therapy as an adjunctive treatment for adults with major depressive disorder (MDD) who failed to achieve satisfactory improvement from at least 1 previous antidepressant medication.¹

The approval under the Class III Premarket Approval pathway was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating ProlivRx in MDD with inadequate response to antidepressant medications.²

"The ProlivRx 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. "This effective and highly accessible therapy with a favorable safety profile, addresses a significant unmet need in this underserved patient population and expands how we can deliver care."

ProlivRx is the first therapy to deliver focal, multi-channel, external combined occipital and trigeminal afferent stimulation therapy. It applies gentle electrical pulses to targeted neural pathways associated with depression, without invasive procedures and with low risk of systemic adverse effects.

"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, MD, 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 remains limited. Now we can offer our patients ProlivRx therapy with continued medical supervision and the convenience of home use. Not only does ProlivRx 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."

Neurolief expects ProlivRx to be available in the US in early 2026 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.

"ProlivRx was developed to extend brain neuromodulation beyond the limitations of traditional clinic-based care," said Scott Drees, CEO of Neurolief. "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."

References

1. Neurolief receives FDA PMA approval for first at-home brain neuromodulation therapy for adults whose depression was not adequately improved by antidepressants. News release. January 12, 2026. Accessed January 12, 2026. https://www.prnewswire.com/news-releases/neurolief-receives-fda-pma-approval-for-first-at-home-brain-neuromodulation-therapy-for-adults-whose-depression-was-not-adequately-improved-by-antidepressants-302658098.html

2. Carpenter LL, George MS, Navarro N, et al. A novel home-based, combined occipital and trigeminal afferent stimulation therapy for major depressive disorder: efficacy and safety results from a double-blind multicenter randomized sham-controlled study. Brain Stimulation. 2025;18(5):1695-1704.