Curated News
By: NewsRamp Editorial Staff
October 09, 2025
NRx Re-files KETAFREE™ Application, Advances Safer Ketamine Treatments
TLDR
- NRx Pharmaceuticals' preservative-free ketamine formulations could capture significant market share by addressing drug shortages and setting new safety standards.
- NRx re-filed an ANDA for KETAFREE, eliminating neurotoxic preservative BZT, while advancing NRX-100 under an NDA with Fast Track Designation for suicidal depression.
- These preservative-free ketamine formulations improve patient safety by removing toxic additives and advancing treatments for suicidal depression and chronic pain.
- NRx is developing multiple ketamine formulations including NRX-101 with Breakthrough Therapy status for suicidal bipolar depression and chronic pain.
Impact - Why it Matters
This development matters because it addresses critical safety concerns in ketamine treatments while expanding access to mental health care. The elimination of neurotoxic preservatives like benzethonium chloride represents a significant advancement in patient safety, particularly for individuals requiring repeated ketamine infusions for conditions like treatment-resistant depression. With mental health crises and suicide rates at alarming levels globally, NRx's preservative-free formulations and specialized depression treatments could provide safer, more effective options for patients who have exhausted conventional therapies. The company's progress comes amid growing ketamine shortages and increasing recognition of ketamine's therapeutic potential, making these developments timely and potentially life-saving for patients with severe depression and suicidal ideation.
Summary
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken significant regulatory steps forward with its innovative ketamine formulations. The company has re-filed an Abbreviated New Drug Application for KETAFREE™, a preservative-free intravenous ketamine formulation designed to eliminate benzethonium chloride (BZT), a known neurotoxic and cytotoxic preservative still present in many current ketamine products. This development follows FDA approval of NRx's Suitability Petition and builds on the company's previous Citizen Petition urging the FDA to ban BZT from all IV ketamine products due to documented long-term health risks.
In parallel with KETAFREE™ development, NRx is advancing NRX-100, a separate preservative-free ketamine formulation under a New Drug Application specifically for 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, potentially accelerating its path to market. The company's pipeline also includes NRX-101, an oral medication for suicidal bipolar depression that holds Breakthrough Therapy Designation and shows potential as a non-opioid treatment for chronic pain. These developments come at a critical time as demand for ketamine treatments rises amid ongoing drug shortages, positioning NRx to capture significant market share while establishing new safety standards in preservative-free IV formulations.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, NRx Re-files KETAFREE™ Application, Advances Safer Ketamine Treatments
