Austin, Texas, United States, September 24th, 2025, FinanceWire
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company’s Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression and PTSD.
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About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression.
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