NRx Pharmaceuticals Resubmits FDA Application for KETAFREETM

NRx Pharmaceuticals, Inc. has re-filed its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for KETAFREETM, a preservative-free intravenous ketamine formulation. This resubmission is aimed at addressing all existing approved indications for the drug. The company’s filing follows the FDA’s approval of its Suitability Petition for the proposed preservative-free strength of ketamine.

KETAFREETM is specifically developed to eliminate the use of benzethonium chloride and other preservatives that have historically been included in ketamine formulations. NRx has requested the FDA to remove benzethonium chloride from all intravenous ketamine products. This request is supported by expert testimony indicating that the compound poses neurotoxic and cytotoxic risks. The company asserts that advancements in manufacturing techniques now ensure long-term stability without the need for preservatives.

Strategic Importance and Market Potential

The resubmission aligns with federal policies aimed at enhancing the availability of strategic drugs. Notably, a presidential executive order issued on May 5, 2025, highlights the urgency of reshoring key medications, including ketamine, due to a significant shortage in the United States. NRx collaborates with Nephron Pharmaceuticals in South Carolina to manufacture the new formulation.

The ketamine market is currently valued at approximately $750 million annually, with projections estimating it could reach $3.35 billion globally by 2034. The rising demand is attributed to drug shortages and an increasing medical application. According to company data, around 5.1 million Americans have received ketamine for medical purposes, a number expected to grow.

KETAFREETM is distinct from NRX-100, another formulation by NRx currently under FDA Fast Track review as a potential treatment for suicidal ideation in depression, including bipolar depression. Should both products receive approval, they will follow separate regulatory pathways and possess unique product codes.

Company Response and Future Outlook

“We appreciate the FDA’s rapid response to our suitability petition and look forward to advancing our preservative-free ketamine presentation to market,” stated Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. He emphasized that KETAFREETM is designed to replace older formulations that rely on potentially harmful preservatives, while also supporting the reshoring of an essential drug to the U.S. The company has also filed a U.S. patent for its innovative preservative-free formulation, which anticipates a shelf stability of three years at room temperature.

NRx is seeking priority review from the FDA, highlighting the ongoing ketamine shortage and the drug’s critical importance in inpatient care. The company aims to expedite the availability of this crucial treatment as healthcare systems around the country continue to navigate increasing demand.