NRx Pharmaceuticals Completes Patient Enrollment in Phase 2b/3 NRX-101 Trial for Suicidal Bipolar Depression

NRx Pharmaceuticals, a biopharmaceutical firm focused on central nervous system (CNS) disorders, has successfully completed the enrollment phase of its Phase 2b/3 clinical trial for NRX-101, a novel medication intended to treat suicidal ideation in patients with treatment-resistant bipolar depression. The trial surpassed its initial target of 70 participants, enrolling a total of 74 individuals to bolster the study's statistical significance. The final patient is anticipated to complete their visit in approximately six weeks, with the data analysis to follow promptly thereafter.

The NRX-101 medication is a unique combination of D-cycloserine, an NMDA antagonist, and lurasidone. This innovative oral treatment has previously demonstrated a reduction in suicidal thoughts among bipolar depression patients, a condition that is known to be highly lethal, with one in five individuals affected by it not surviving. The medication has been granted the Breakthrough Therapy Designation by the FDA, and the current trial aims to reaffirm its efficacy in alleviating both depressive symptoms and suicidal thoughts.

Dr. Jonathan Javitt, the Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, expressed gratitude to the investigators, trial sites, and patients involved in the study. He highlighted the potential of NRX-101 to offer a life-saving oral treatment option for patients who currently have limited treatment options, such as electroconvulsive therapy (ECT).

The Phase 2b/3 trial, registered on www.clinicaltrials.gov with the identifier NCT 03395392, is a randomized, prospective, multicenter, double-blind study that compares the effects of NRX-101 against lurasidone over a period of six weeks. The study is led by Prof. Andrew Nierenberg from Harvard Massachusetts General Hospital. The primary measure of effectiveness is the reduction in depressive symptoms as indicated by the MADRS scale, while the secondary outcome is the reduction in suicidal ideation as measured by the CGI-SS scale. The trial has reported a treatment compliance and concordance rate of over 94%, which is notably higher than the CNS trial industry standard.

NRx Pharmaceuticals is in the clinical stage of development and is creating therapeutics based on its NMDA platform to address a range of CNS disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company has partnered with Alvogen Pharmaceuticals for the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. Additionally, NRX-101 is being considered as a non-opioid treatment for chronic pain and as a therapy for complicated urinary tract infections.

Recently, NRx Pharmaceuticals announced its intention to submit a New Drug Application for ketamine to treat suicidal depression, supported by well-controlled clinical trials conducted by the US National Institutes of Health and data obtained from French health authorities under a data sharing agreement. The company has also received Fast Track Designation from the US FDA for the development of ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality.

The company's recent achievements are a testament to its commitment to advancing treatment options for severe CNS disorders, offering hope to patients in desperate need of new therapeutic alternatives.