NRx Pharmaceuticals files ANDA for preservative-free IV ketamine

NRx Pharmaceuticals (NRXP) announced the transmission of its Abbreviated New Drug Application for electronic filing to the U.S. FDA for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management. The current annual ketamine market is estimated at $750M, with global demand for ketamine projected to grow to $3.35B 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 that existing market. The company anticipates filing 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. Management believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of closely related benzalkonium chloride in current drug products. Preservatives were originally added to sterile injectable products in an era when a single vial of medication was used to treat multiple patients, a practice no longer allowed in U.S. hospitals. NRx has demonstrated that there is no need for such preservatives to maintain stability and sterility in ketamine presentations intended for single-patient use. Should the citizen’s petition be granted, all formulations of ketamine sold in the US could face a regulatory requirement to be preservative free. This filing supplements the New Drug Application currently being completed by the company to extend the labeled indications of ketamine to include the treatment of suicidal depression. The company anticipates submitting clinical trials 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.