Curated News
By: NewsRamp Editorial Staff
September 29, 2025

NRx Re-files FDA Application for Safer Ketamine Amid Drug Shortage

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TLDR

  • NRx Pharmaceuticals gains competitive advantage with its preservative-free KETAFREE formulation targeting a $750 million U.S. ketamine market amid ongoing drug shortages.
  • NRx Pharmaceuticals re-filed its ANDA with the FDA for KETAFREE, a preservative-free IV ketamine manufactured with Nephron Pharmaceuticals using a patented formulation.
  • KETAFREE provides a safer ketamine alternative free of benzethonium chloride, addressing neurotoxicity concerns and improving treatment safety for patients with CNS disorders.
  • NRx's KETAFREE targets a ketamine market projected to reach $3.35 billion globally by 2034 with its patented preservative-free formulation.

Impact - Why it Matters

This development matters because ketamine has emerged as a crucial treatment for severe depression and other mental health conditions, particularly for patients who haven't responded to traditional antidepressants. The current drug shortage creates significant barriers to care for vulnerable populations. NRx's preservative-free formulation addresses safety concerns associated with benzethonium chloride, which has been linked to neurotoxicity. If approved, KETAFREE™ could provide a safer alternative during a critical period when access to ketamine treatments is limited, potentially improving outcomes for patients suffering from treatment-resistant depression, PTSD, and chronic pain while setting new safety standards in the rapidly expanding ketamine market.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken a significant step forward by re-filing its Abbreviated New Drug Application with the U.S. FDA for KETAFREE™, a preservative-free intravenous ketamine formulation. This strategic move follows the FDA's approval of its Suitability Petition and positions the company to capitalize on a ketamine market estimated at $750 million annually in the U.S., with global projections reaching $3.35 billion by 2034. The timing is particularly crucial given the ongoing drug shortage, and NRx is seeking priority review for its patented formulation manufactured in partnership with Nephron Pharmaceuticals in South Carolina.

The core innovation behind KETAFREE™ lies in its elimination of benzethonium chloride, a preservative linked to neurotoxicity concerns, making it a potentially safer alternative for patients requiring ketamine treatment. NRx Pharmaceuticals is developing this product as part of its broader NMDA platform targeting central nervous system disorders, including suicidal depression, chronic pain, and PTSD. The company's pipeline also includes NRX-101, an oral D-cycloserine/lurasidone combination, with both NRX-100 (the preservative-free IV ketamine) and NRX-101 having received significant regulatory designations including Fast Track and Breakthrough Therapy Designations for treating suicidal depression.

This development represents a critical advancement in the InvestorBrandNetwork's Dynamic Brand Portfolio, where InvestorWire serves as a specialized communications platform providing advanced wire-grade press release syndication and comprehensive corporate communications solutions. The re-filing demonstrates NRx's commitment to addressing serious mental health conditions while potentially improving patient safety through its innovative preservative-free formulation. For investors and stakeholders following NRXP, this milestone represents meaningful progress in the company's clinical development strategy and market positioning within the growing ketamine therapeutics space.

Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NRx Re-files FDA Application for Safer Ketamine Amid Drug Shortage

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