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NRx Pharmaceuticals Begins Selling U.S.-Made, Preservative-Free Ketamine Amid Long-Running Shortage

NRXP
  • NRx Pharmaceuticals commenced sales operations this week with a 17-person sales force covering customers responsible for approximately 80% of current U.S. ketamine sales.
  • Initial supply agreements and preorders are targeted for late 2026, with product shipments scheduled to begin in January 2027.
  • Efficiencies from blow-fill-seal manufacturing & the sales structure are expected to generate gross & net sales margins exceeding 50%.
  • The product is a preservative-free, FDA-approved ketamine injection in a needle-free drug/device combination vial designed to address the shortage existing since 2018.
  • NRx contracted with German suppliers to expand blow-fill-seal manufacturing lines in South Carolina to double its U.S. sterile injectable footprint.
  • The new packaging eliminates benzethonium chloride, an inactive ingredient the FDA has not deemed generally recognized as safe & effective, while reducing sharps injuries & waste.
  • The blow-fill-seal process reduces cost of goods sold to less than 20% compared to 70% or more for traditional glass bottles, restoring commercial viability to older sterile drugs.
  • Customers indicate a willingness to enter long-term agreements for a guaranteed U.S.-manufactured supply with a two-year expiration, unlike the 90-day limit for compounded alternatives.
  • NRx filed a citizen petition with the FDA to remove benzethonium chloride from ketamine based on an expert toxicology report documenting potential exposure levels exceeding safety limits.
  • The company holds an Abbreviated New Drug Approval for the preservative-free ketamine presentation & seeks New Drug Approval for NRX-100 to treat depression & suicidality.
  • In October 2026, the Defense Advanced Research Projects Agency awarded an $11.25 million contract for a phase 3 trial of the oral drug NRX-101 combined with robotic transcranial magnetic stimulation.
Company
NRx Pharmaceuticals Inc
Keywords
Nasdaq:NRXP, NRx Pharmaceuticals Inc