Curated News
By: NewsRamp Editorial Staff
October 17, 2025

NRx Pharma Advances Dual Preservative-Free Ketamine Therapies

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TLDR

  • NRx Pharmaceuticals is advancing preservative-free ketamine therapies through dual regulatory pathways, potentially gaining market advantage with KETAFREE and NRX-100 formulations.
  • NRx refiled an ANDA for KETAFREE after FDA approval to remove neurotoxic preservative BZT, while pursuing NDA for NRX-100 with Fast Track Designation.
  • Preservative-free ketamine therapies eliminate neurotoxic chemicals, improving patient safety and advancing mental health treatment for depression and suicidal ideation.
  • NRx's dual approach includes KETAFREE for existing ketamine uses and NRX-100 targeting suicidal depression, both removing harmful preservatives linked to neurotoxicity.

Impact - Why it Matters

This development matters because it addresses critical safety concerns in ketamine therapy while expanding treatment options for severe mental health conditions. The elimination of benzethonium chloride (BZT) preservative could reduce neurotoxicity risks associated with current ketamine formulations, potentially making treatment safer for patients with treatment-resistant depression, bipolar disorder, and suicidal ideation. Given the growing mental health crisis and the limitations of existing antidepressants, improved ketamine therapies could provide life-saving alternatives for patients who haven't responded to conventional treatments. The dual regulatory approach also demonstrates pharmaceutical innovation in bringing safer medications to market more efficiently.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is pursuing an innovative dual-path strategy to bring preservative-free ketamine-based therapies to market. The company recently refiled its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation intended for all currently approved ketamine indications. This filing follows the FDA's approval of NRx's Suitability Petition to eliminate benzethonium chloride (BZT), a chemical preservative still found in many ketamine formulations that has been associated with neurotoxicity and cytotoxic effects. The removal of this potentially harmful preservative represents a significant advancement in ketamine therapy safety.

In parallel with the KETAFREE™ development, NRx is advancing NRX-100, another preservative-free ketamine formulation being pursued under a New Drug Application (NDA) specifically targeting suicidal ideation in depression, including bipolar depression. NRX-100 holds Fast Track Designation from the FDA and may qualify for the agency's National Priority Voucher Program, potentially accelerating its path to market. The company also continues development work on NRX-101, which has Breakthrough Therapy designation for suicidal bipolar depression. CEO Dr. Jonathan Javitt recently discussed these pipeline developments and veteran-focused clinical collaborations during the Noble Capital Markets Emerging Growth Virtual Equity Conference, highlighting the company's comprehensive approach to addressing serious mental health conditions through improved ketamine formulations.

Source Statement

This curated news summary relied on content disributed by NewMediaWire. Read the original source here, NRx Pharma Advances Dual Preservative-Free Ketamine Therapies

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