Curated News
By: NewsRamp Editorial Staff
December 02, 2025

NRx Pharma's KETAFREE Gets FDA Review Date, Targets Safer Ketamine

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TLDR

  • NRx Pharmaceuticals gains a potential market advantage with KETAFREE's FDA submission, targeting approval by July 2026 for a safer ketamine alternative.
  • The FDA received NRx Pharmaceuticals' ANDA for KETAFREE, a preservative-free intravenous ketamine formulation, with a review goal date set for July 29, 2026.
  • KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines, potentially improving patient safety and supporting domestic supply-chain priorities.
  • NRx Pharmaceuticals' KETAFREE offers a single-patient, preservative-free alternative to current ketamine vials containing Benzethonium Chloride, which the FDA no longer recognizes as safe.

Impact - Why it Matters

This development matters because it addresses a critical safety issue in ketamine therapy, which is increasingly used for depression and pain. Current multidose vials contain Benzethonium Chloride, a preservative the FDA no longer deems safe, posing risks to patients. KETAFREE offers a preservative-free, single-patient alternative, potentially reducing adverse effects and improving treatment outcomes. For individuals relying on ketamine for severe conditions like suicidal depression or chronic pain, this could mean safer, more effective care. From a broader perspective, it aligns with public health initiatives to eliminate toxic substances from medications and strengthens domestic pharmaceutical supply chains, enhancing drug security. If approved, it may accelerate access to innovative therapies, setting a new standard for drug formulation safety in mental health treatment.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has achieved a significant regulatory milestone as the FDA has received and deemed "substantially complete" its Abbreviated New Drug Application (ANDA) for KETAFREE™. This preservative-free intravenous ketamine formulation now has a formal review goal date of July 29, 2026. According to CEO Jonathan Javitt, KETAFREE is designed as a critical single-patient alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound the FDA no longer recognizes as safe. The company emphasizes that this development aligns with broader Medication Access and Healthcare Affordability (MAHA) initiatives aimed at removing toxic substances from medicines and supports domestic supply-chain priorities, positioning NRx for potential approved drug sales in 2026 if the application proceeds on schedule.

The KETAFREE program is distinct from NRx's other major therapeutic candidate, NRX-100, which has Fast Track designation for the treatment of suicidal depression. NRx continues to advance its broader pipeline, which targets central nervous system disorders including chronic pain and PTSD, and its HOPE Therapeutics clinics. The company's development portfolio also includes NRX-101, an oral therapy with Breakthrough Therapy Designation for suicidal bipolar depression. For those seeking more details, the full press release is available to view, providing comprehensive insights into this announcement and the company's strategic direction. Investors and stakeholders can find further information on the InvestorBrandNetwork website, which hosts the original content.

This news underscores NRx Pharmaceuticals' commitment to innovating safer pharmaceutical formulations. By addressing the safety concerns associated with preservatives like Benzethonium Chloride, KETAFREE represents a proactive step toward enhancing patient care in ketamine-based therapies. The company's engagement with regulatory pathways, including the ANDA submission and the pursuit of a National Priority Voucher for NRX-100, highlights its focus on accelerating access to critical treatments. As the biopharmaceutical industry increasingly prioritizes drug safety and supply chain resilience, NRx's efforts with KETAFREE could set a precedent for future developments, making it a key player to watch in the evolving landscape of mental health and pain management therapeutics.

Source Statement

This curated news summary relied on content disributed by NewMediaWire. Read the original source here, NRx Pharma's KETAFREE Gets FDA Review Date, Targets Safer Ketamine

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