U.S. Military Seeks Fast-Track Approval for Dissolvable Ketamine Wafers as Combat Pain Treatment

Summary

The U.S. Department of Defense has awarded a nearly $41 million sole-source contract to Singapore-based iX Biopharma to develop Wafermine, a sublingual ketamine wafer designed to dissolve under the tongue and deliver pain relief to wounded soldiers on the battlefield. The company is now pursuing emergency FDA authorization to make the drug available to troops before full FDA approval is granted, made possible by a September declaration from Health and Human Services Secretary Robert Kennedy Jr. following Defense Secretary Pete Hegseth's determination of a military emergency involving heightened risk of chemical, biological, radiological, or nuclear attacks. Unlike traditional ketamine injections, the wafer allows the drug to be absorbed directly through the mucous membrane into the bloodstream, offering a more practical and non-opioid pain management solution in combat environments. Research supports this shift, as a 2023 study confirmed that ketamine use by the U.S. military has been steadily rising as a primary analgesic for combat casualties while opioid use has declined. However, the effort has encountered complications, as a Politico investigation revealed that iX Biopharma's domestic manufacturing partner lacks the required Nevada operating license.