The US Meals and Drug Administration (FDA) has authorised Neurolief Inc’s ProlivRx, the primary prescription, physician-directed, at-home mind neuromodulation remedy as an adjunctive remedy for adults with main depressive dysfunction (MDD) who failed to realize passable enchancment from at the very least 1 earlier antidepressant remedy.1
The approval underneath the Class III Premarket Approval pathway was supported by scientific proof from the MOOD Examine, a randomized, managed, multicenter scientific trial, evaluating ProlivRx in MDD with insufficient response to antidepressant drugs.2
“The ProlivRx pivotal research outcomes symbolize an vital new possibility for sufferers who haven’t responded adequately to drugs,” mentioned Mark S. George, MD, a principal investigator of the MOOD scientific trial and professor of psychiatry and neurology on the Medical College of South Carolina. “This efficient and extremely accessible remedy with a good security profile, addresses a big unmet want on this underserved affected person inhabitants and expands how we will ship care.”
ProlivRx is the primary remedy to ship focal, multi-channel, exterior mixed occipital and trigeminal afferent stimulation remedy. It applies light electrical pulses to focused neural pathways related to despair, with out invasive procedures and with low threat of systemic adversarial results.
“Till now, sufferers combating difficult-to-treat despair didn’t have a non-pharmacological remedy possibility that could possibly be administered at dwelling”, mentioned Linda Carpenter, MD, principal investigator of the MOOD scientific trial, professor of psychiatry at Brown College, and director of the Neuromodulation Program at Butler Hospital. “Despite the fact that there’s a large want for brand new remedy approaches when antidepressant drugs aren’t working, entry to interventional psychiatry providers like transcranial magnetic stimulation stays restricted. Now we will supply our sufferers ProlivRx remedy with continued medical supervision and the comfort of dwelling use. Not solely does ProlivRx introduce a novel mechanism for noninvasive neuromodulation via its actions on the occipital and trigeminal neural pathways, but it surely additionally establishes a brand new remedy paradigm by making evidence-based neuromodulation extensively accessible, past the partitions of the specialty clinic.”
Neurolief expects ProlivRx to be out there within the US in early 2026 via licensed prescribers, with preliminary deployment centered on well being methods, behavioral well being packages, and built-in care settings looking for scalable options for sufferers who haven’t adequately responded to antidepressant remedy.
“ProlivRx was developed to increase mind neuromodulation past the restrictions of conventional clinic-based care,” mentioned Scott Drees, CEO of Neurolief. “Sufferers who do not reply adequately to antidepressants face sensible boundaries to accessing clinic-based remedy. We’re excited to make this remedy out there to physicians and their sufferers.”
References
1. Neurolief receives FDA PMA approval for first at-home mind neuromodulation remedy for adults whose despair was not adequately improved by antidepressants. Information launch. January 12, 2026. Accessed January 12, 2026.
2. Carpenter LL, George MS, Navarro N, et al.