NRXP Completes Final Patient Visit in NRX-101 Phase 2b/3 Bipolar Depression Trial

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the completion of the last evaluable patient's visit in its Phase 2b/3 clinical trial of NRX-101, a proprietary combination drug targeting suicidal treatment-resistant bipolar depression. The database from the study is currently being cleaned and locked, with statistical analysis and top-line data expected soon. Positive results from this trial could trigger a milestone payment and further development responsibilities will shift to Alvogen.

NRX-101 has received Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement from the FDA for the treatment of suicidal bipolar depression. This unique medication has shown promise in reducing suicidal thoughts in patients with bipolar depression, a condition that can be fatal in about 20% of sufferers.

According to Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, this is the first known clinical trial involving patients with suicidal bipolar depression in an outpatient setting. A previous trial tested NRX-101's ability to sustain the antidepressant and anti-suicidal effects of hospital-administered ketamine. While some patients experienced worsening depression requiring hospitalization, overall patient safety was maintained, and no serious unexpected adverse events were reported.

The Phase 2b/3 trial is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over a six-week period. The trial's Principal Investigator is Professor Andrew Nierenberg from Harvard Massachusetts General Hospital. The primary efficacy endpoint is a reduction in depression as measured by the MADRS scale, and the secondary endpoint is a reduction in suicidal ideation evaluated using the Clinical Global Impression Suicidality Scale (CGI-SS). High treatment compliance and concordance rates between local and central raters were reported, exceeding industry norms in CNS trials.

NRx Pharmaceuticals focuses on developing treatments for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. Their lead candidate, NRX-101, is an investigational therapy designated as a Breakthrough Therapy by the FDA for treating suicidal, treatment-resistant bipolar depression and chronic pain. NRx has strategic partnerships with Alvogen and Lotus for the development and commercialization of NRX-101.

Additionally, NRx Pharmaceuticals has announced plans to submit a New Drug Application for HTX-100 (IV ketamine) through its subsidiary, Hope Therapeutics. This submission is based on data from clinical trials supported by the US National Institutes of Health and newly acquired data from French health authorities under a data-sharing agreement. The FDA has granted Fast Track Designation to their development of ketamine (NRX-100) for treating acute suicidality.

Hope Therapeutics, wholly owned by NRx Pharmaceuticals, is dedicated to developing and marketing an FDA-approved intravenous form of ketamine for acute suicidality and depression, alongside a digital therapeutic platform to enhance and sustain the clinical benefits of NMDA-targeted therapies.