NRx Pharmaceuticals re-files abbreviated NDA for KETAFR

NRx Pharmaceuticals (NRXP), “announced the re-filing of its Abbreviated New Drug Application to the U.S. Food and Drug Administration for KETAFREE(TM), 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 Company previously filed a citizen’s petition with the FDA to remove benzethonium chloride, 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.”