- The company targets all current ketamine indications, including anesthesia and pain management.
- The U.S. is facing a severe ketamine shortage, prompting NRx to seek priority FDA review.
- NRX-100 eliminates benzethonium chloride, aligning with U.S. health initiatives to remove toxic preservatives.
- The company plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products.
- The filing complements the company’s NDA for NRX-100 for suicidal depression, with a PDUFA date expected in late 2025.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for NRX-100, a preservative-free formulation of ketamine. The submission seeks approval for all existing ketamine indications, including its use in anesthesia and pain management (https://ibn.fm/hsgzo).
The move comes amid a significant shortage of ketamine in the United States, as noted by the American Society of Health-System Pharmacists. With demand rising and supply constrained, the company is…
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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