Pentagon seeks emergency authorization for sublingual ketamine wafer to treat battlefield casualties

The U.S. Department of Defense is accelerating development of a sublingual ketamine wafer for treating moderate-to-severe acute pain in military casualties and is pursuing an Emergency Use Authorization from the Food and Drug Administration.

The product, Wafermine, is being developed by Singapore-based iX Biopharma under a $40.95 million Defense Department contract awarded in February.

Wafermine is a rapidly dissolving sublingual wafer containing racemic ketamine. It is designed to deliver the drug through the oral mucosa into the bloodstream without intravenous access, making it potentially useful in battlefield, emergency and remote-care settings.

The 36-month Pentagon program funds Phase 3 clinical development and work required for an FDA Emergency Use Authorization, which could allow military use before the drug receives full FDA approval.

That is not the same as bypassing the FDA. An EUA is itself an FDA regulatory pathway intended for emergency circumstances and still requires the agency to evaluate available evidence on safety, effectiveness and risk-benefit.

The Defense Department opened an emergency-use pathway in September for drugs treating moderate-to-severe acute pain in military casualties, clearing iX Biopharma to advance its Wafermine application.

The company says the treatment has shown rapid pain relief in earlier clinical studies, typically beginning within about 10 minutes, but Wafermine has not yet received full U.S. approval for this use.

The Pentagon’s push comes as the U.S. military prepares for high-intensity conflicts in which large numbers of casualties and disrupted medical evacuation could increase demand for fast, needle-free pain treatment.