NRx Pharmaceuticals Completes FDA Meeting on NRX-100 for Suicidal Depression
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals Inc. (NASDAQ: NRXP) completed an in-person Type C guidance meeting with the U.S. Food and Drug Administration regarding NRX-100, its preservative-free intravenous ketamine formulation for treating suicidal depression. The meeting was conducted by leaders from the FDA Division of Psychiatry Products, the FDA Office of Neuroscience and the FDA Center for Drug Evaluation and Research.
Based on oral guidance received during the meeting, the company believes it has a path to file a New Drug Application for NRX-100 supported by existing adequate and well-controlled trials and confirmatory evidence from more than 65,000 patients in a Real World Evidence dataset. The company plans to seek a broader indication for NRX-100 to serve patients with treatment-resistant depression in the context of suicidality.
Preliminary feedback from the FDA indicates that no additional nonclinical data will be necessary for the application, nor will bridging studies be required to support the preservative-free formulation. The company will work with the agency to finalize a statistical analysis protocol, with further details to follow upon receipt of formal meeting minutes.
NRx estimates approval could provide access to a $2 billion ketamine market currently served by intranasal S-ketamine. NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression.
The company has also filed an Abbreviated New Drug Application with the FDA, which was received in September 2025. NRx anticipates a decision by summer 2026 for its preservative-free ketamine formulation, designed to replace current ketamine preparations that contain benzethonium chloride.
The company recently eliminated $5.4 million in balance sheet debt through an equity conversion with Anson Funds LLC, where outstanding debt was exchanged for common stock. NRx operates HOPE Therapeutics, a subsidiary with medical clinics combining neuroplastic drugs with Transcranial Magnetic Stimulation, Hyperbaric Oxygen Therapy and psychotherapy. The company has signed contracts to purchase 10 interventional psychiatry clinics in California and Florida.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone). NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.