The Pentagon is moving to add ketamine wafers to its battlefield medicine options, and the push carries a clear sense of urgency. The medication is designed to dissolve beneath the tongue, offering troops a potential alternative to ketamine injections for treating acute pain.

Earlier this year, the War Department awarded iX Biopharma a development contract worth nearly $41 million. The Singapore company is developing Wafermine, a small wafer filled with ketamine that patients absorb under the tongue.

The manufacturer recently announced that it is seeking an emergency authorization that could make Wafermine available to troops before the medication receives full approval from the Food and Drug Administration. The company cited a September U.S. declaration concerning a military emergency and the emergency use of drugs considered necessary by the Pentagon.

A federal emergency use approval declaration from the U.S. Department of Health and Human Services opened a possible route for earlier official authorization. Issued Sept. 3, the declaration gives the Food and Drug Administration a path to permit unapproved medications for treating war wounds.

That federal action followed a determination made by War Secretary Pete Hegseth on July 15. According to the notice, Hegseth determined there was “a military emergency, or significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with a chemical, biological, radiological, or nuclear agent or agents,” affecting American forces.

The notice said such an attack could also involve agents capable of causing life threatening injuries. It did not provide additional details about the circumstances behind the emergency determination.

The declaration continued: “Injuries arising from these attacks may cause those forces to experience moderate to severe acute pain and place them at risk of developing life-threatening hemodynamic instability, including shock or respiratory distress.”

Because of Hegseth’s determination, Health and Human Services Secretary Robert Kennedy, Jr. declared that “circumstances exist justifying the authorization of emergency use of drugs” identified by the Pentagon. That step created the possibility that selected medications could receive emergency authorization before securing full federal approval.

The notice, however, did not identify which drugs the Pentagon would select for emergency authorization. It also did not elaborate on the military emergency circumstances cited by Hegseth.

A Politico investigation published Tuesday raised another issue surrounding the Wafermine effort. The investigation found that iX Biofarma’s domestic manufacturing partner does not possess the Nevada license required to operate.

iX Biofarma described Wafermine as a medication that does not use opioids and called it the “world’s first sublingual ketamine for acute moderate to severe pain.” The company said the wafer provides a different delivery method by allowing ketamine to pass through the mucous membrane and enter the bloodstream.

Ketamine is typically administered through an injection. According to the source material, the drug can alleviate pain, increase euphoria and cause dissociation and amnesia.

A 2023 study examined the use of opioids and ketamine for battlefield injuries between January 2010 and December 2019. It found that opioid use declined during that period while ketamine use increased.

The researchers concluded that “ketamine is generally used first for more severely injured patients and has increasingly been employed by the U.S. military as the primary analgesic for combat casualties.” Their findings provide context for the Pentagon’s interest in another way to deliver the drug to wounded personnel.

The company said it received a “sole-source” award for the development of Wafermine. According to the source, that meant other vendors were not solicited for the work.

The nearly $41 million contract, the federal emergency declarations and the manufacturer’s pursuit of emergency authorization place Wafermine on an accelerated path toward potential military use. Full Food and Drug Administration approval has not yet been granted, and the federal notice did not confirm that Wafermine itself would receive emergency authorization.