NRx Pharmaceuticals Inc. (NASDAQ: NRXP) has taken a significant step towards addressing the critical shortage of ketamine in the United States by filing an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free formulation of ketamine. This development is crucial as it targets all current ketamine indications, including anesthesia and pain management, at a time when the American Society of Health-System Pharmacists has highlighted a severe shortage of the drug.
The application for NRX-100 is notable for its elimination of benzethonium chloride, a move that aligns with broader U.S. health initiatives aimed at removing toxic preservatives from medical products. NRx Pharmaceuticals plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products, a step that could have far-reaching implications for patient safety and product standards in the pharmaceutical industry.
This filing is part of NRx Pharmaceuticals' broader strategy, complementing its 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 company's efforts to introduce a preservative-free ketamine formulation come at a pivotal moment, offering a potential solution to the ongoing shortage while advancing the push for safer, more effective medical treatments.
