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By: NewMediaWire
October 17, 2025

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NRx Pharmaceuticals (NRXP) Pursues Dual Pathway for Preservative-Free Ketamine-Based Therapies

LOS ANGELES, CA - October 17, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is advancing a two-pronged approach to bring preservative-free ketamine-based therapies to market, pursuing distinct regulatory and commercial pathways for both KETAFREE(TM) and NRX-100. (https://ibn.fm/BYg97). The company recently refiled an Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free intravenous (“IV”) ketamine formulation intended for all currently approved ketamine indications.

  • The company has refiled its Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free IV ketamine formulation.
  • The filing follows FDA approval of the company’s Suitability Petition to remove benzethonium chloride (“BZT”), a preservative linked to neurotoxicity.
  • In parallel, NRx is advancing NRX-100, another preservative-free ketamine formulation under a New Drug Application (“NDA”) for suicidal ideation in depression, including bipolar depression.
  • NRX-100 holds Fast Track Designation and may qualify for the FDA’s National Priority Voucher Program.
  • The company also continues work on NRX-101, a Breakthrough Therapy for suicidal bipolar depression.
  • CEO Dr. Jonathan Javitt recently discussed new pipeline developments and veteran-focused clinical collaborations during the Noble Capital Markets Emerging Growth Virtual Equity Conference.

This filing follows the U.S. Food and Drug Administration’s approval of NRx’s Suitability Petition to eliminate benzethonium chloride (“BZT”), a chemical preservative still found in many ketamine formulations. BZT, a quaternary ammonium compound, has been associated with cytotoxic and…

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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.

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