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Posted On: 08/04/2025 4:19:54 PM
Post# of 201
NetworkNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Petitions FDA to Ban Benzethonium Chloride from Ketamine Products
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the U.S. BZT, a quaternary amine preservative, is not Generally Recognized as Safe (GRAS) for parenteral use or Generally Recognized as Safe and Effective (GRASE) for topical use, and has demonstrated toxicity to epithelial cells and nerves. NRx previously submitted an Abbreviated New Drug Application for a preservative-free ketamine formulation with three-year room temperature stability and sterility, supported by a newly filed patent. The company is also pursuing a labeled indication for suicidal depression under the FDA Commissioner’s National Priority Voucher Program. CEO Dr. Jonathan Javitt noted that ketamine’s current use in treating conditions like suicidal depression and PTSD exposes patients to a preservative banned in other applications, aligning the petition with federal efforts to eliminate toxic additives from the drug supply.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the U.S. BZT, a quaternary amine preservative, is not Generally Recognized as Safe (GRAS) for parenteral use or Generally Recognized as Safe and Effective (GRASE) for topical use, and has demonstrated toxicity to epithelial cells and nerves. NRx previously submitted an Abbreviated New Drug Application for a preservative-free ketamine formulation with three-year room temperature stability and sterility, supported by a newly filed patent. The company is also pursuing a labeled indication for suicidal depression under the FDA Commissioner’s National Priority Voucher Program. CEO Dr. Jonathan Javitt noted that ketamine’s current use in treating conditions like suicidal depression and PTSD exposes patients to a preservative banned in other applications, aligning the petition with federal efforts to eliminate toxic additives from the drug supply.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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