Curated News
By: NewsRamp Editorial Staff
December 02, 2025

FDA Accepts NRx Pharma's KETAFREE Application, Sets 2026 Review Date

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TLDR

  • NRx Pharmaceuticals gains a potential market advantage with FDA acceptance of KETAFREE, targeting 2026 sales by offering a safer, preservative-free alternative to current ketamine vials.
  • The FDA deemed NRx's ANDA for KETAFREE substantially complete, setting a July 29, 2026 review date for this single-patient, preservative-free intravenous ketamine formulation.
  • KETAFREE removes toxic substances from medicine, aligning with MAHA initiatives to improve patient safety and support domestic supply chains for better healthcare access.
  • NRx's KETAFREE program advances separately from its Fast Track depression treatment, showcasing the company's broader pipeline development in central nervous system disorders.

Impact - Why it Matters

This news matters because it addresses a critical safety issue in ketamine-based treatments, which are increasingly used for severe depression, chronic pain, and PTSD. Current multidose vials contain Benzethonium Chloride, a preservative the FDA has deemed unsafe, posing risks to patients. KETAFREE offers a preservative-free, single-patient alternative, aligning with efforts to eliminate toxic substances from medicines. If approved by the 2026 deadline, it could enhance treatment safety and accessibility, potentially reducing side effects and improving outcomes for vulnerable populations. For investors, it signals NRx Pharmaceuticals' regulatory progress and pipeline strength, while for the healthcare system, it supports supply-chain resilience and patient care standards in mental health and pain management.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has achieved a significant regulatory milestone with its KETAFREE™ product. The U.S. Food and Drug Administration (FDA) has accepted the company's Abbreviated New Drug Application (ANDA) for KETAFREE, a preservative-free intravenous ketamine formulation, deeming the submission "substantially complete" and setting a review goal date of July 29, 2026. According to CEO Jonathan Javitt, this innovation addresses a critical safety concern by offering a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride—a compound the FDA no longer recognizes as safe. The company emphasizes that KETAFREE aligns with broader MAHA (Medication Access and Health Affordability) initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential approved drug sales projected for 2026 if the FDA grants approval on schedule.

This development is part of NRx Pharmaceuticals' broader pipeline, which focuses on central nervous system disorders such as suicidal depression, chronic pain, and PTSD through its NMDA platform. The KETAFREE program is distinct from NRX-100, the company's Fast Track-designated treatment for suicidal depression, and NRX-101, which has Breakthrough Therapy Designation for suicidal bipolar depression. NRx continues to advance its clinical programs and HOPE Therapeutics clinics, reinforcing its commitment to innovative therapeutics. For more details, investors and interested parties can view the full press release via the provided hyperlink. The company's progress is also tracked through resources like the InvestorBrandNetwork, which offers extensive distribution and communication services for public companies.

NRx Pharmaceuticals' strategic moves highlight its role in the biopharmaceutical sector, leveraging platforms like InvestorWire to enhance visibility and engagement. The acceptance of the ANDA for KETAFREE not only marks a step forward in drug safety but also positions the company for potential market entry in the coming years, contributing to the evolving landscape of mental health and pain management treatments. This news underscores the importance of regulatory advancements and patient-centric innovations in healthcare, with implications for investors, healthcare providers, and patients awaiting safer therapeutic options.

Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, FDA Accepts NRx Pharma's KETAFREE Application, Sets 2026 Review Date

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