NRx Pharmaceuticals (NASDAQ: NRXP) Pursues Dual Pathway for Preservative-Free Ketamine-Based Therapies
- 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.
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.
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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COMTEX_469587975/2801/2025-10-17T11:03:43
