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LOS ANGELES, CA - August 13, 2025 (NEWMEDIAWIRE) - 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.
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NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
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Forward Looking Statements
Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.
