Austin, Texas, United States, September 30th, 2025, FinanceWire
NRx Pharmaceuticals (NASDAQ: NRXP) announced it has re-filed its Abbreviated New Drug Application with the U.S. FDA for KETAFREE(TM), a preservative-free IV ketamine formulation, covering all existing approved indications, following FDA approval of its Suitability Petition. Targeting a ketamine market estimated at $750 million annually in the U.S. and projected to reach $3.35 billion globally by 2034, NRx is seeking priority review amid an ongoing drug shortage, citing its patented formulation manufactured with Nephron Pharmaceuticals in South Carolina as a safer alternative free of benzethonium chloride, a preservative linked to neurotoxicity.
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About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. 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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