NRx Pharmaceuticals Wins FDA Approval for Preservative-Free Ketamine; NRXP Jumps 16.6% Pre-Market

NRx Pharmaceuticals Inc. (NRXP) said the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for preservative-free ketamine, ahead of the agency's November 10 goal date. The stock rose 16.60% to $3.12 in pre-market trading after closing Thursday at $2.66, down 1.12%. The formulation excludes benzethonium chloride (BZT), an antimicrobial preservative in currently available ketamine injection products that the FDA has not designated Generally Recognized as Safe. NRx cited a toxicology report indicating patients at commonly used hospital and clinic doses may be exposed to BZT levels above the FDA's published maximum daily exposure limit. NRx said it holds commercial supply and can now label and distribute to U.S. hospitals and clinics, where ketamine injection is used primarily for anesthesia and pain control. The drug remains on the FDA shortage list. Nephron Pharmaceuticals will manufacture the product at its West Columbia, South Carolina facility using blow-fill-seal technology. NRXP shares have traded between $1.62 and $5.05 over the past 52 weeks.