WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has re-filed its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for KETAFREE™, a preservative-free intravenous ketamine formulation, for all existing approved indications. The filing follows FDA approval of the company’s Suitability Petition for the proposed strength of preservative-free ketamine.
KETAFREE™ is designed to eliminate benzethonium chloride and other preservatives historically added to ketamine formulations. NRx has petitioned the FDA to remove benzethonium chloride from all intravenous ketamine products, citing expert testimony that the compound is neurotoxic and cytotoxic. The company emphasized that modern manufacturing techniques allow long-term stability without the use of preservatives.
The filing also aligns with federal policy priorities. A May 5, 2025, Presidential executive order directed reshoring of strategic drugs, including ketamine, which faces a severe U.S. shortage. NRx manufactures the new formulation in partnership with Nephron Pharmaceuticals in South Carolina.
The ketamine market is currently valued at about $750 million annually and is projected to reach $3.35 billion globally by 2034. Demand has been heightened by drug shortages and increased medical use. According to NRx, an estimated 5.1 million Americans have received ketamine for medical purposes, a figure expected to rise.
KETAFREE™ is distinct from NRX-100, the company’s formulation under FDA Fast Track review as a potential therapy for suicidal ideation in depression, including bipolar depression. Should both products be approved, they would carry separate regulatory pathways and product codes.
“We appreciate FDA’s rapid response to our suitability petition and look forward to advancing our preservative-free ketamine presentation to market,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “KETAFREE™ is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility, and to reshore the manufacture of a strategically-important drug to the US. We have filed a US patent on our novel, preservative-free formulation, which anticipates three years of room-temperature shelf stability.”
NRx said it is seeking priority review from the FDA, citing the ongoing ketamine shortage and the drug’s critical role in inpatient care.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.