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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of a Citizen Petition with the US Food and Drug Administration Seeking Removal of Benzethonium Chloride from Ketamine Products
Sterile ketamine products currently for sale in the United States contain benzethonium chloride, a preservative with known toxicity that is not Generally
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Sterile ketamine products currently for sale in the United States contain benzethonium chloride, a preservative with known toxicity that is not Generally Recognized as Safe and Effective by the US Food and Drug AdministrationFDA has previously prohibited the use of benzethonium chloride in hand cleansers and topical antisepticsSubstantial precedent exists for removal of toxic preservatives from vaccines, eyedrops, and other pharmaceutical productsThe Company has filed data with FDA that documents the long-term stability and sterility of preservative-free ketamine for intravenous useWILMINGTON, Del., Aug. 4, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, today announced the filing of a Citizen Petition with the US Food and Drug Administration (FDA), seeking the removal of Benzethonium Chloride from all forms of ketamine sold in the United States. Benzethonium Chloride (BZT) is a preservative with known toxicity that is not Generally Recognized as Safe (GRAS) by the FDA for parenteral products and not Generally Recognized as Safe and Effective (GRASE) for topical products. It belongs to a class of quaternary amine preservatives that is known to be toxic to epithelial cells and to demonstrate neurotoxicity. This class of preservatives has been removed from many eyedrops because of demonstrated toxicity to the conjunctiva and corneal nerves. The FDA no longer allows BZT to be used in hand cleansers and topical antiseptics.1\n\n \n \n \n \n \n \n\n \nIn June 2025 NRx filed an Abbreviated New Drug Application with the FDA for a preservative-free preparation of ketamine, demonstrating support for 3 year room temperature stability and sterility. NRx has similarly filed a patent on its preservative-free process, in light of prior art that suggested BZT was required for long term stability and sterility. The Company has instituted US-based high volume manufacture, while it awaits generic approval. The Company is additionally seeking a labeled indication for the use of ketamine to treat suicidal depression through the recently-announced FDA Commissioner's National Priority Voucher Program.\n\"At its introduction in the 1970s, ketamine was developed as an anesthetic and was never intended to be administered repeatedly to patients,\" said Dr. Jonathan Javitt, CEO of NRx Pharmaceutica...