• The company targets all current ketamine indications, including anesthesia and pain management.
• The U.S. is facing a severe ketamine shortage, prompting NRx to seek priority FDA review.
• NRX-100 eliminates benzethonium chloride, aligning with U.S. health initiatives to remove toxic preservatives.
• The company plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products.
• The filing complements the company’s NDA for NRX-100 for suicidal depression, with a PDUFA date expected in late 2025.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for NRX-100, a preservative-free formulation of ketamine. The submission seeks approval for all existing ketamine indications, including its use in anesthesia and pain management (https://ibn.fm/hsgzo).

The move comes amid a significant shortage of ketamine in the United States, as noted by the American Society of Health-System Pharmacists. With demand rising and supply constrained, the company is requesting a priority review from the FDA.

NRX-100 is designed without benzethonium chloride, a compound recognized for its neurotoxic and cytotoxic properties. Its absence positions NRX-100 in line with broader public health efforts to eliminate harmful preservatives from medications. NRx plans to file a citizen’s petition urging the FDA to mandate preservative-free formulations for all ketamine intended for IV use.

The company aims to leverage the existing $750 million U.S. ketamine market and growing global demand, which is projected to reach $3.35 billion by 2034. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime, a number that continues to grow. With ketamine use expanding in both hospital settings and psychiatric care, NRx believes NRX-100 could gain traction among providers seeking safer alternatives.

Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals, commented on the ANDA submission’s timing in the context of a rapidly expanding market and an inadequate available supply. “We at NRx believe that safer, preservative-free formulations of ketamine will be increasingly preferred by physicians, patients, and regulators in this large and growing market,” Javitt said. “NRX-100 is designed to replace older formulations that rely on potentially neurotoxic and cytotoxic preservatives for stability and sterility. We have filed a U.S. patent on our novel, preservative-free formulation, which anticipates three years of room-temperature shelf stability.”

The move supplements NRx’s New Drug Application (“NDA”) currently underway for NRX-100 in the treatment of suicidal depression. That submission is expected to be reviewed by the FDA in late 2025 under the Prescription Drug User Fee Act (“PDUFA”).

Clinical data backing the NDA includes studies involving more than 1,000 patients and observational data from over 180,000 individuals. The company argues that NRX-100 has demonstrated non-inferiority to electroconvulsive therapy and superiority to both placebo and active placebo in reducing suicidality.

In April 2025, NRx secured a waiver of the $4.3 million NDA filing fee, citing the product’s public health relevance and the company’s small business status. The company was previously granted Fast Track designation for NRX-100 as part of a broader protocol in suicidal bipolar depression.

NRx is also pursuing patent protection for NRX-100, with claims extending through 2045. The formulation is designed to remain stable at room temperature for three years, which the company sees as another advantage over older ketamine products.

The company hopes that its preservative-free formulation can potentially set a new standard for ketamine delivery. In the context of increasing ketamine use for mental health and chronic pain, NRX-100 may become a safer alternative with fewer toxicity concerns. The combination of regulatory positioning, clinical backing, and public health alignment puts NRx in a unique position to compete in a sector undergoing both supply disruption and therapeutic evolution.

For more information, visit the company’s website at www.NRxPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP

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