WILMINGTON, DE — NRx Pharmaceuticals Inc. (NASDAQ: NRXP) has secured U.S. Food and Drug Administration approval for a preservative-free injectable ketamine product, positioning the company to supply American hospitals and clinics amid a prolonged shortage of the anesthetic.
The FDA approved the company’s Abbreviated New Drug Application ahead of its Nov. 10 regulatory goal date, authorizing a formulation that eliminates benzethonium chloride, an antimicrobial preservative used in existing ketamine injections.
NRx plans to manufacture the product domestically through a partnership with Nephron Pharmaceuticals in West Columbia, South Carolina, using automated blow-fill-seal technology rather than traditional glass-vial production.
The approval creates a new supply option for ketamine injection, which NRx says has faced shortages since 2018 and remains on the FDA’s drug shortage list.
The company reported that commercial inventory has already been manufactured, allowing it to proceed with labeling and distribution to healthcare facilities.
Ketamine is used primarily for anesthesia and pain management in hospitals and clinics, including certain procedures involving labor and delivery. NRx is separately developing treatments targeting depression, post-traumatic stress disorder and suicidality.
The newly approved formulation also addresses a preservative-related concern raised by NRx.
According to the company, currently available ketamine injections contain benzethonium chloride, a substance subject to FDA restrictions in several product categories because of toxicological concerns.
NRx has petitioned the FDA to remove benzethonium chloride from ketamine formulations, citing an expert toxicology assessment submitted to the agency.
The assessment, commissioned by the company, concluded that patients receiving ketamine at doses routinely administered in clinical settings could be exposed to benzethonium chloride above a published FDA maximum daily exposure threshold of 1 milligram.
Those findings represent the company’s regulatory position and do not establish that existing FDA-approved ketamine products are unsafe.
NRx Chairman and Chief Executive Officer Jonathan Javitt characterized the approval as an opportunity to provide clinicians with an alternative for patients requiring repeated treatment.
“We are excited to bring Preservative-Free Ketamine to market and to give patients and their physicians an option for repeat treatments without the potential dangers of a preservative,” Javitt stated.
Beyond the formulation change, NRx is seeking to establish a domestic manufacturing model for sterile injectable medications that have historically depended on overseas production.
The company maintains that blow-fill-seal manufacturing can support higher-volume production in the United States and reduce reliance on labor-intensive manufacturing processes.
The approval follows the FDA’s review of the company’s generic drug application through its Office of Generic Drugs. It also provides NRx with an approved commercial product alongside its broader pharmaceutical development programs.
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