NRX-101 Phase 2b/3 Data Lock Achieved in Suicidal Bipolar Depression Trial

NRx Pharmaceuticals, currently in the clinical stage, has announced achieving a significant milestone in their Phase 2b/3 trial of NRX-101 for Suicidal Treatment Resistant Bipolar Depression. The data lock indicates that all data from the study have been handed over for independent statistical analysis, with the top-line results expected in April 2024. If the study yields positive outcomes and secures FDA approval, NRx Pharmaceuticals will receive the remainder of their initial milestone payment from partners Alvogen and Lotus Pharmaceuticals. Future development costs for this indication will also be taken over by these partners, while NRx retains rights for other indications like chronic pain and PTSD.

NRX-101 stands out as it has garnered several FDA designations, including Breakthrough Therapy Designation and Fast Track Designation, for treating a severe form of bipolar depression marked by suicide risk. This is significant as it is currently the only oral treatment showing efficacy in reducing both depressive and suicidal symptoms among bipolar patients—a condition that leads to a high rate of mortality.

The study has its roots in the STABIL-B trial, which set the precedent by earning the Breakthrough Therapy Designation for NRX-101 to be used following ketamine administration. This prior success led the FDA to clear a Phase III trial under a Special Protocol Agreement. In the recent trial, the FDA suggested broadening the scope to include outpatients with subacute suicidality to potentially expand the use of NRX-101 from thousands to millions of patients annually.

Dr. Jonathan Javitt, the Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, outlined that previous oral antidepressant trials excluded patients with active suicidal ideation. The ongoing trial of NRX-101 marks the first under the FDA's Investigational New Drug application aimed at creating an oral therapy alternative to the currently approved electroconvulsive therapy for suicidal bipolar depression. Also, a New Drug Application for ketamine as a brief therapy for suicidal bipolar depression is planned. Dr. Javitt emphasized the successful enrollment and treatment of suicidal patients thanks to rigorous monitoring, attributing this achievement to the dedication of their clinical team and the cooperation of trial participants.

This pivotal trial, listed under clinicaltrials.gov (NCT 03395392), is a rigorous six-week, double-blind, multicenter study comparing NRX-101 with lurasidone. The trial is led by Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary endpoint is a reduction in depression severity (Montgomery-Asberg Depression Rating Scale), while the secondary endpoints include a reduction in suicidal thoughts (Clinical Global Impression Suicidality Scale). Compliance and rating concordance in the study were exceptionally high at over 94%.

About NRx Pharmaceuticals:

NRx Pharmaceuticals is devoted to developing NMDA-based treatments for central nervous system disorders, including bipolar depression, chronic pain, and PTSD. NRX-101, designed for treatment-resistant bipolar depression, is particularly noteworthy due to its several FDA designations and potential future applications. Collaborations with Alvogen and Lotus focus on marketing this innovative treatment. Additionally, NRx plans to submit a New Drug Application for HTX-100 (IV ketamine) as a therapy for suicidal depression, aiming to provide new clinical solutions based on well-controlled trials and new data from French health authorities.