NRx Pharmaceuticals Completes Enrollment for NRX-101 Trial in Bipolar Depression

On January 22, 2024, NRx Pharmaceuticals, Inc. revealed that they have completed participant enrollment for their Phase 2b/3 clinical trial of NRX-101, a proprietary combination of the NMDA antagonist D-cycloserine and lurasidone for treating Suicidal Treatment Resistant Bipolar Depression. The enrollment included 74 patients, surpassing the initial target of 70 to strengthen the study's statistical validity. Success in this trial will trigger a milestone payment from Alvogen, who will then oversee further development and market introduction for this treatment.

Dr. Jonathan Javitt, the founder and Chief Scientist of NRx Pharmaceuticals, highlighted that NRX-101 is a pioneering oral medication shown to decrease suicidal thoughts in bipolar depression patients. This disease is particularly lethal, claiming the lives of one in five who suffer from it. Due to promising results from previous trials, the FDA granted NRX-101 Breakthrough Therapy Designation. The current trial aims to validate its efficacy against depression and suicidal ideation. Javitt expressed gratitude to the study investigators, trial sites, and patients, emphasizing the goal of providing a lifesaving at-home oral medication as an alternative to the existing electroconvulsive therapy (ECT).

The ongoing Phase 2b/3 trial is a multicenter, double-blind study that has randomized participants to either NRX-101 or lurasidone over a six-week period. The principal investigator for this study is Professor Andrew Nierenberg from Harvard Massachusetts General Hospital. The primary efficacy endpoint is the reduction in depression severity as measured by the MADRS scale, while the secondary endpoint is the reduction of suicidal ideation measured by the Clinical Global Impression Suicidality Scale (CGI-SS). The trial has reported a treatment compliance rate of over 94%, surpassing the industry norm for CNS clinical trials.

The results of this study are anticipated to be released later in the quarter.

About NRx Pharmaceuticals: NRx Pharmaceuticals is a biopharmaceutical company at the clinical stage, specializing in developing treatments based on its NMDA platform aimed at central nervous system disorders like suicidal bipolar depression, chronic pain, and PTSD. Their leading product, NRX-101, is designed as a treatment for suicidal treatment-resistant bipolar depression and chronic pain and has been designated as a Breakthrough Therapy by the FDA. NRx is collaborating with Alvogen Pharmaceuticals for the development and commercialization of NRX-101. Furthermore, NRX-101 shows potential as a non-opioid solution for chronic pain and a treatment for complicated urinary tract infections (UTIs).

NRx Pharmaceuticals has also announced plans to file a New Drug Application for ketamine to treat suicidal depression. This application is backed by rigorous clinical trials conducted under the guidance of the US National Institutes of Health and supplemented by new data from French health authorities. The FDA has granted Fast Track Designation to the development of ketamine (NRX-100) as part of a protocol aimed at treating patients with acute suicidality.