NRx Pharmaceuticals Seeks FDA Approval for Preservative-Free Ketamine Amid National Shortage

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has taken a significant step towards addressing the critical ketamine shortage in the United States by filing an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for NRX-100. This new formulation is a preservative-free version of ketamine, targeting all current indications including anesthesia and pain management. The move is timely, as the American Society of Health-System Pharmacists has highlighted a severe shortage of ketamine, with rising demand outpacing supply.

The company's initiative to eliminate benzethonium chloride, a toxic preservative, from NRX-100 aligns with broader U.S. health initiatives aimed at removing harmful substances from medical products. NRx Pharmaceuticals plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products, a move that could set a new standard for safety in ketamine-based treatments. This filing complements the company's New Drug Application (NDA) for NRX-100 for the treatment of suicidal depression, with a Prescription Drug User Fee Act (PDUFA) date anticipated in late 2025.

The development of NRX-100 could have far-reaching implications for the medical community and patients alike. By providing a safer, preservative-free alternative, NRx Pharmaceuticals is not only addressing the immediate shortage but also contributing to the long-term improvement of ketamine-based therapies. The company's efforts reflect a growing recognition of the importance of ketamine in treating a range of conditions, from severe depression to chronic pain, and underscore the need for innovative solutions to current challenges in drug formulation and supply.