Curated News
By: NewsRamp Editorial Staff
October 08, 2025

NRx Re-files KETAFREE(TM) ANDA, Advances Safer Ketamine Treatments

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TLDR

  • NRx Pharmaceuticals' preservative-free ketamine formulations position the company to capture significant market share amid rising ketamine demand and ongoing drug shortages.
  • NRx re-filed an ANDA for KETAFREE(TM) to eliminate neurotoxic preservative BZT while advancing NRX-100 under an NDA with Fast Track Designation for suicidal depression treatment.
  • NRx's preservative-free ketamine formulations eliminate toxic additives, potentially improving patient safety and setting new standards for IV medications while addressing serious mental health conditions.
  • NRx is developing multiple ketamine formulations including NRX-101 with Breakthrough Therapy Designation for suicidal bipolar depression, advancing novel treatments for challenging mental health conditions.

Impact - Why it Matters

This development matters because it addresses significant safety concerns in ketamine treatments that affect millions of patients worldwide. Traditional ketamine formulations contain benzethonium chloride, a preservative with documented neurotoxic and cytotoxic properties that could cause long-term harm to patients receiving repeated treatments. With ketamine becoming an increasingly important treatment for depression, chronic pain, and other conditions, safer alternatives are urgently needed. NRx's preservative-free formulations could revolutionize ketamine therapy by eliminating these risks while maintaining therapeutic efficacy. Furthermore, the company's focus on suicidal depression treatments comes at a critical time when mental health crises are rising globally, and existing treatments often fall short. The potential for these developments to provide safer, more effective options for patients with treatment-resistant conditions represents a substantial advancement in psychiatric and pain management care.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken significant steps forward in developing safer ketamine treatments by re-filing an Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation. This move follows FDA approval of NRx's Suitability Petition and represents a crucial advancement in addressing safety concerns surrounding traditional ketamine formulations. The company's KETAFREE(TM) product is specifically designed to eliminate benzethonium chloride (BZT), a known neurotoxic and cytotoxic preservative that remains present in many current ketamine formulations. NRx had previously submitted a Citizen Petition urging the FDA to ban BZT from all IV ketamine products, citing substantial long-term health risks and filing supporting toxicology evidence to bolster their case for safer alternatives.

In parallel to the KETAFREE(TM) development, NRx is advancing NRX-100, a separate preservative-free ketamine formulation being pursued under a New Drug Application for the treatment of suicidal depression, including bipolar depression. NRX-100 has received Fast Track Designation from the FDA, and the company aims to qualify for the FDA's National Priority Voucher Program, which could accelerate the development and approval process. The two products—KETAFREE(TM) and NRX-100—will follow distinct regulatory and commercial paths, allowing NRx to address multiple therapeutic areas with their innovative preservative-free formulations. Additionally, NRx is developing NRX-101, an oral medication for suicidal bipolar depression that holds Breakthrough Therapy Designation, further expanding their pipeline of central nervous system disorder treatments.

With rising demand for ketamine therapies and ongoing drug shortages in the healthcare sector, NRx aims to capture a significant market share while setting a new standard in preservative-free IV formulations. The company's broader development focus includes therapeutics based on its NMDA platform for treating central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia, while also exploring its potential as a non-opioid treatment for chronic pain and complicated UTI. The company's recent initiatives, including the New Drug Application filing for NRX-100 based on results from well-controlled clinical trials conducted under the U.S. National Institutes of Health and newly obtained data from French health authorities, position NRx as an innovative player in the biopharmaceutical landscape addressing critical mental health and pain management needs.

Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NRx Re-files KETAFREE(TM) ANDA, Advances Safer Ketamine Treatments

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