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NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today announced the re-filing of its Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for KETAFREE™, its preservative-free IV ketamine formulation, for use in all existing approved indications. The filing follows FDA grant of approval of its Suitability Petition for NRx's proposed strength of preservative-free ketamine.
The current annual ketamine market is estimated at $750 million, with global demand for ketamine projected to grow to $3.35 billion by 2034. This does not include the widespread use of compounded ketamine by clinics unable to obtain manufactured drug. NRx aims to capture a significant share of the current market. According to a 2021 survey, an estimated 5.1 million Americans had received ketamine for medical uses in their lifetime3, a number that continues to grow with increased clinical focus on this important medication. Ketamine currently faces a severe drug shortage according to the American Society of Hospital Pharmacists. Accordingly, NRx is seeking priority review from FDA.
The Company previously filed a citizen's petition with the FDA to remove benzethonium chloride (BZT), a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use. The FDA has previously disallowed the use of BZT in hand cleansers and topical antiseptics. A related preservative, benzalkonium chloride has demonstrated corneal and conjunctival toxicity in artificial tears and glaucoma medications, leading to use of preservative-free alternatives. NRx has filed expert testimony from accredited toxicologists regarding the toxicity of BZT, which is not generally recognized as safe (GRAS) by the FDA. Removal of potentially harmful preservatives from foods is a stated priority in the MAHA report and HHS leadership has additionally targeted preservatives in vaccines. BZT was originally added to ketamine when it was first formulated in the 1970s to maintain stability and sterility using the container closure systems then available. NRx has demonstrated long term stability and sterility with a patented preservative-free formulation using modern manufacturing methods.
Return of strategic drugs to US manufacture (Reshoring) is a current US priority as stated in a Presidential executive order issued on May 5, 2025. This initiative particularly applies to drugs that are critical for inpatient care, such as ketamine. The NRx product is manufactured in partnership with Nephron Pharmaceuticals of West Columbia, SC.
The formulation filed under the ANDA is distinct from that used in the New Drug Application (NDA), for which the Company has received Fast Track Designation for Treatment of Suicidal Ideation in Depression, including Bipolar Depression. The Company anticipates submitting clinical trial data from more than 1,000 patients and real-world data from more than 180,000 patients in which ketamine demonstrated superiority to placebo and active placebo, with noninferiority to electroconvulsive therapy. Should both the ANDA and the NDA be approved, the resulting commercial products would have different, non-substitutable product numbers and different commercial paths.
Posted In: NRXP
