WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has accepted its Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine product that could reshape a global market estimated at roughly $750 million a year.
The agency told NRx the application is “substantially complete” and set a Generic Drug User Fee Amendments (GDUFA) review deadline of July 29, 2026. If approved, KETAFREE would become the first single-patient ketamine presentation formulated without Benzethonium Chloride, a preservative long used in multidose vials but no longer permitted in new sterile drugs.
“We appreciate FDA’s careful review and are pleased that it has received our application for KETAFREE,” said Jonathan Javitt, NRx’s chairman and CEO. He noted that existing ketamine products rely on preservatives dating back to the 1970s, when multidose vials were used for multiple patients — a practice now prohibited in U.S. healthcare settings.
NRx argues that Benzethonium Chloride is outdated and potentially harmful, pointing to its removal from modern sterile injectables and its restriction from hand cleansers and topical antiseptics. The company has a pending citizen petition urging the FDA to require all ketamine manufacturers to eliminate the compound entirely.
KETAFREE is intended for all approved ketamine indications and is manufactured in the United States, aligning with federal efforts to secure domestic production of essential medicines. The company said it has already produced registration lots and is prepared to scale manufacturing to 1 million vials per month.
The FDA recently awarded a Commissioner’s National Priority Voucher to a U.S. maker of ketamine active pharmaceutical ingredient, underscoring ketamine’s strategic role in the national drug supply — a signal NRx believes strengthens the case for a preservative-free alternative.
NRx has also filed for KETAFREE to become the product’s proprietary name, pending FDA review. The company said an on-time approval could enable meaningful commercial sales in 2026 with profitability consistent with analyst expectations.
KETAFREE is separate from the company’s NRX-100 program, an innovative therapy in development for suicidal depression that has received Fast Track designation.
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