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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine
Ketamine faces a current US drug shortage not expected to abate in the near future1Current ketamine market estimated at $750 million and projected to reach
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Ketamine faces a current US drug shortage not expected to abate in the near future1Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.2 NRx anticipates marketing ketamine for all approved usesCompany anticipates priority review based on current and anticipated drug shortageNRX-100 to provide innovative, preservative-free IV ketamine formulation to eliminate benzethonium chloride preservative, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugsThe Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from all presentations of ketamine intended for intravenous useThis filing complements the ongoing NDA submission for NRX-100 in suicidal depression; PDUFA anticipated in late 2025WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management.\n\n \n \n \n \n \n \n\n \nThe current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. This does not include the widespread use of compounded ketamine by clinics unable to obtain manufactured drug. NRx aims to capture a significant share of that existing market. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime3, a number that continues to grow with increased clinical focus on this important medication. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacist with no short-term abatement. Accordingly, NRx is seeking priority review from FDA.\nThe Company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. Management believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxic...