Curated News
By: NewsRamp Editorial Staff
September 30, 2025

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

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TLDR

  • NRx Pharmaceuticals' KETAFREE offers a competitive edge in the $750M U.S. ketamine market with a safer, preservative-free formulation during a drug shortage.
  • NRx Pharmaceuticals re-filed its FDA application for KETAFREE, a preservative-free IV ketamine manufactured with Nephron Pharmaceuticals using a patented formulation without benzethonium chloride.
  • KETAFREE provides a safer ketamine treatment free of neurotoxic preservatives, improving patient care for depression, chronic pain, and PTSD amid ongoing shortages.
  • NRx's KETAFREE is a preservative-free IV ketamine targeting a global market projected to reach $3.35 billion by 2034, offering a neurotoxin-free alternative.

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, while safety concerns about existing formulations have limited broader adoption. A preservative-free option could expand treatment access, reduce side effects, and potentially save lives among patients with treatment-resistant depression and suicidal ideation. As mental health crises continue to rise globally, safer and more accessible ketamine treatments represent an important advancement in psychiatric care.

Summary

NRx Pharmaceuticals (NASDAQ: NRXP) has taken a significant step forward in addressing critical healthcare needs by re-filing its Abbreviated New Drug Application with the U.S. FDA for KETAFREE™, a preservative-free intravenous ketamine formulation. The company is strategically positioning itself within a ketamine market estimated at $750 million annually in the United States alone, with global projections reaching $3.35 billion by 2034. This regulatory milestone follows FDA approval of NRx's Suitability Petition and comes at a crucial time when healthcare providers are grappling with ongoing drug shortages. The company's patented formulation, manufactured in partnership with Nephron Pharmaceuticals in South Carolina, represents a potentially safer alternative to existing ketamine treatments by eliminating benzethonium chloride, a preservative that has been linked to neurotoxicity concerns.

The clinical-stage biopharmaceutical company is leveraging its NMDA platform to develop therapeutics for central nervous system disorders, with KETAFREE™ targeting all existing approved ketamine indications. NRx is actively seeking priority review from regulatory authorities, emphasizing the urgent need for safer treatment options amid the current drug shortage landscape. The company's broader pipeline includes NRX-100, which has received Fast Track Designation for treating Suicidal Ideation in Depression, and NRX-101, awarded Breakthrough Therapy Designation for suicidal bipolar depression. These designations underscore the significant unmet medical needs in mental health treatment and position NRx as an important player in the evolving landscape of neuropsychiatric therapeutics. For those seeking comprehensive details, the full press release is available through the InvestorBrandNetwork website.

Source Statement

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

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