The Cradle
According to a report by Politico, the US War Department is fast-tracking the procurement of sublingual ketamine wafers for battlefield trauma management, pushing for emergency regulatory clearance to bypass standard Food and Drug Administration (FDA) approval cycles.
The move follows a $41 million sole-source development contract awarded earlier this year to Singapore-based iX Biopharma to produce “Wafermine”—a fast-dissolving sublingual wafer designed to deliver high-potency ketamine directly into the bloodstream through the oral mucous membrane.
The rapid push toward emergency authorization stems from a September declaration by War Secretary Pete Hegseth, who formally cited a heightened risk of CBRN (chemical, biological, radiological, or nuclear) attacks and high-intensity combat scenarios capable of causing mass casualty events.
Under the federal declaration, Health and Human Services Secretary Robert F. Kennedy Jr. determined that emergency conditions exist to justify the deployment of unapproved, specialized analgesics to prevent severe shock and hemodynamic instability among wounded combat personnel.
The Pentagon’s shift toward sublingual ketamine underscores an evolving tactical medicine strategy that prioritizes rapid, non-opioid pain management in extreme combat environments where intravenous administration is impractical.
However, the program faces immediate logistical and regulatory hurdles following reports that iX Biopharma’s primary domestic manufacturing partner currently lacks the required state licensing in Nevada to operate, drawing increased scrutiny from federal lawmakers over the expedited sole-source procurement process.
