A nearly $41 million Defense Department development contract could expand options for treating wounded U.S. troops, as the manufacturer explores emergency authorization before full FDA approval.
WASHINGTON | The Pentagon is pursuing a dissolvable ketamine wafer designed to treat moderate to severe pain in wounded service members, backing the technology with a development contract worth nearly $41 million as its manufacturer seeks a potential pathway to emergency use before full federal approval.
Singapore-based pharmaceutical company iX Biopharma is developing Wafermine, a ketamine-based medication administered beneath the tongue rather than through an injection. The proposed treatment could provide military medical personnel with another option for managing acute pain in battlefield casualties.
The declaration does not constitute FDA approval of Wafermine or establish that the medication has been authorized for battlefield deployment.
The regulatory effort follows a Sept. 3 declaration by the Department of Health and Human Services, which determined that circumstances exist to justify potential emergency authorization of drugs identified by the Defense Department.
According to the federal notice, Defense Secretary Pete Hegseth determined July 15 that a military emergency, or significant potential for one, involved heightened risks to U.S. forces from chemical, biological, radiological or nuclear agents, or other attacks capable of causing life-threatening injuries.
The declaration cited the potential for severe pain, shock and respiratory distress among affected service members.
Health and Human Services Secretary Robert F. Kennedy Jr. subsequently issued a declaration establishing a legal basis for the FDA to consider emergency use authorizations for qualifying medications.
The notice did not identify specific drugs for authorization or explain the operational circumstances behind the military emergency determination.
An emergency use authorization can permit the use of certain unapproved medical products, or unapproved uses of approved products, when statutory requirements are met. It is distinct from full FDA approval and requires the agency to evaluate the available evidence, potential benefits and risks.
Wafermine uses a sublingual delivery system, allowing ketamine to be absorbed through tissues beneath the tongue and enter the bloodstream.
Ketamine is an anesthetic and pain-management medication already used in military and civilian medicine. It can provide significant pain relief but may also cause dissociation, sedation and changes in perception, making appropriate dosing and patient monitoring important
Unlike injectable ketamine, the wafer formulation is intended to provide an alternative method of administration. Its effectiveness, safety and suitability for battlefield conditions remain subject to regulatory review.
iX Biopharma has described Wafermine as a sublingual ketamine treatment for acute moderate to severe pain.
The Defense Department's interest comes as military medicine continues to evaluate alternatives to opioid-based pain management for combat casualties.
A study published in 2023 examining battlefield analgesic use from January 2010 through December 2019 found that opioid administration declined while ketamine use increased.
Researchers reported that ketamine was increasingly used as a primary pain medication for severely wounded service members.
The findings reflect the military's longstanding interest in treatments that can manage traumatic injury pain while addressing the operational challenges of casualty care.
In combat environments, medics may need to stabilize wounded personnel before evacuation, sometimes with limited equipment, supplies or access to advanced medical facilities.
A noninjectable pain medication could potentially expand treatment options, although its practical advantages would depend on clinical evidence, administration requirements and performance under operational conditions.
The company's development program also faces manufacturing and regulatory questions.
A Politico investigation reported that iX Biopharma's domestic manufacturing partner lacked a Nevada license required for its operations. The reported licensing issue raises questions about the manufacturing arrangements supporting the proposed medication.
The manufacturer has described the Defense Department contract as a sole-source award, indicating that the contract was awarded without a competitive solicitation open to multiple bidders.
The reported contract value represents development funding, not confirmation that Wafermine has received regulatory authorization or that the Pentagon has begun issuing the medication to troops.
Several questions remain unresolved, including when the manufacturer might submit an emergency authorization request, what supporting clinical evidence would be provided and whether the FDA would determine that the product meets the legal requirements for emergency use.
The Defense Department's specific plans for distributing or administering Wafermine in military medical settings also have not been established in the information released.
The next significant development will depend on the manufacturer's regulatory submission and the FDA's review, along with any further Pentagon decisions on testing, procurement and potential operational use.
For military medical planners, the program represents an effort to broaden battlefield pain-management capabilities. Whether the ketamine wafer becomes an authorized treatment option will depend on the evidence supporting its safety, effectiveness and suitability for military use.
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-- By Leticia Jacobs
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