A Proven Medicine; A New Prescription Form; A Trustworthy Option to Treat Depression

While good mental health is a foundation of overall well-being, good care options remain inadequate.  

Over 200 million people worldwide live with depression, and up to 10 million have treatment-resistant disease, where prior therapies have failed repeatedly. [1]  

To address this need, Neurocentrx is developing NRCx-201, a new drug- and software combination investigational product designed to offer a trusted prescription for psychiatrists and their patients to safely access the rapid-acting antidepressant effects of ketamine-based care.  

We aim that NRCx-201 will be the first FDA-approved ketamine treatment to combine our patented abuse-deterrent capsule with prescription safety software containing in-built, regulator-approved safety standards and ongoing care support. If approved, we believe NRCx-201 may provide the first regulated ketamine care option where a more convenient capsule dose can be safely administered across both clinical and home-care settings.  

Psychiatrists and their patients currently struggle to navigate and access ketamine-based depression care: while effective, ketamine can only be prescribed as IV or nasal spray, and abuse and safety concerns mean these expensive treatments must only occur in clinical settings.   

NRCx-201 is designed to be a regulated, safe, but a more accessible ketamine care alternative. Subject to FDA approval and ongoing regulatory control of the product post-approval, NRCx-201 offers:  

• enhanced patient safety through comprehensive digital safety prescription care tools, combined with  

• a drug capsule built according to FDA abuse-deterrence standards, as a further product assurance necessary for safe treatment in community-based settings  

The safety standard of NRCx-201 will be supported by comprehensive clinical trials and the ongoing delivery of safety evidence via real-world digital prescription care data, as intended for a product subject to permanent drug safety controls.  

Through our prior Phase 1 safety studies and upcoming Phase 2 and Phase 3 trials in treatment-resistant major depressive disorder and bipolar II depression, we will provide substantial clinical evidence to demonstrate a ketamine-based prescription care standard that is safe and scalable.   

With sound evidence, regulatory acceptance, and ongoing safe control of product care and patient safety, we believe NRCx-201 can offer relief and a renewed quality of life for individuals living with severe mood disorders well into the future.  

Reference

1. Institute of Health Metrics and Evaluation. Global Health Data Exchange (GHDx).  https://vizhub.healthdata.org/gbd-results/ (Accessed 4 March 2023).