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Pentagon Seeks Ketamine Wafers as Battlefield Painkiller Option

Singapore-based iX Biopharma's Wafermine is in development, and a Nevada manufacturing license question has surfaced

By AXY Defense Desk ·

The Pentagon, the Headquarters of the US Department of Defense. Photo was taken from a commercial airliner during the early morning sometime in September 2018.
The Pentagon, the Headquarters of the US Department of Defense. Photo was taken from a commercial airliner during the early morning sometime in September 2018.

Key points

The Pentagon wants ketamine wafers, and it appears to want them soon. Earlier this year the Defense Department awarded a nearly $41 million development contract to Singapore-based iX Biopharma to develop Wafermine, a small wafer packed with ketamine that dissolves under the tongue. Now the drug's maker says it is pursuing an emergency authorization that could put the medication in the hands of troops before the Food and Drug Administration grants full approval.

Why the Pentagon Is Looking at a Dissolving Wafer

Ketamine is not new to medicine. Doctors have used it for decades as an anesthetic, and it is also used to relieve pain. It is usually given by injection, and it can cause dissociation, a feeling of detachment from one's surroundings, as well as amnesia. Because of those effects and its potential for misuse, it is a tightly controlled drug in the United States.

Wafermine changes how the drug gets into the body. According to iX Biopharma, the wafer lets patients absorb the ketamine through the mucous membrane under the tongue and into the bloodstream. That means no needle and no intravenous line is required to deliver the dose. For a medic treating a wounded soldier under fire, that difference could matter a great deal.

The company has described the product in strong terms. It called the non-opioid medication the “world's first sublingual ketamine for acute moderate to severe pain.” Sublingual simply means taken under the tongue. The wording signals that the company wants the product to be seen as a pain option that does not rely on opioids, the class of drugs that includes morphine and fentanyl.

A September Emergency Declaration Opens a Faster Route

The Food and Drug Administration normally requires a lengthy review before a new drug can be marketed. An emergency use authorization is a separate route. It lets the agency allow unapproved medical products to be used during a declared emergency, and it generally depends on a federal declaration that such an emergency exists.

That is where the recent paperwork comes in. A federal emergency use declaration by the U.S. Department of Health and Human Services on Sept. 3 opened the possibility of early official authorization, giving the FDA a route to use unapproved medications to treat war wounds.

The chain of decisions started earlier. According to the notice, on July 15 Defense Secretary Pete Hegseth determined “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,” or an attack with agents that would cause life-threatening injuries. The declaration continues: “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. In plain terms, the Pentagon names the drugs it needs, and the health department's declaration is what allows the FDA to move faster on them.

This could be the key to Wafermine's timeline. Without an emergency authorization, the wafer would have to go through the standard approval process before troops could receive it. The emergency route would allow the military to reach for it sooner, though it would not give the product full approval.

Ketamine's Growing Role on the Battlefield

The Pentagon's interest is not based on a new idea. A 2023 study found that opioid use to relieve battlefield injuries decreased between January 2010 and December 2019, while ketamine use increased over the same period.

The researchers explained the shift in their findings. They wrote 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.” An analgesic is a pain reliever, so the researchers were describing ketamine becoming a main pain treatment for the most seriously hurt troops.

That trend helps explain the appeal of a wafer. Opioids carry well-known risks, including addiction and overdose, and they can also cause breathing problems. A non-opioid option that medics can give without an IV could make pain control simpler in chaotic conditions. Still, the study describes injection-based ketamine use, so any shift to a wafer would be a new step in how the drug is delivered.

The Nevada License Question

A Politico investigation found that iX Biopharma's domestic manufacturing partner lacks the Nevada license required to operate. A license of that kind is what allows a facility to make a regulated product in a given state, so the gap matters for any plan that depends on American production.

The finding does not automatically stop the program. It does raise a practical question about where and how Wafermine would be made if the company moves toward emergency use. A medication cannot reach troops in quantity without a production line that is legally allowed to run.

For readers, the issue is simple. A promising drug is only useful if it can be made reliably and on schedule. A licensing problem at a domestic partner could slow supply, even if the science and the military's interest remain intact.

Questions Around the $41 Million Contract

The company said it received a “sole-source” award for Wafermine development, meaning it did not solicit other vendors. In other words, the Defense Department chose one developer without opening the work to competition.

Sole-source awards are not unusual when the government believes only one company can meet a specific need. They do, however, draw extra scrutiny because taxpayers' money is involved and rival firms do not get a chance to bid. The contract is nearly $41 million, which is a large sum for a single development effort.

The source material does not show that the award was improper. It does show why the Nevada licensing finding and the sole-source arrangement will likely be examined together by anyone tracking the program.

Where the Wafermine Plan Goes From Here

The next test is whether the emergency authorization moves forward. The company has said it is pursuing that route, and the September declaration gives the FDA a legal path to consider unapproved products for war wounds. How quickly the agency acts will determine whether troops could see Wafermine before a full approval.

The Nevada license finding is the second test. This could be resolved by the domestic partner obtaining the required license or by shifting production to a facility that already has the right approvals. Either path would take time, and the timeline would shape how realistic early deployment is.

Third, the development contract itself will need to produce results. The Pentagon is paying for a product that must prove it can deliver pain relief safely and reliably in the field. Clinical and manufacturing milestones will matter more than announcements.

For now, the story is about a clear military interest and a fast-moving regulatory route. The Pentagon wants a non-opioid pain option that medics can use without a needle, and the company is trying to supply it. Whether that happens quickly will depend on paperwork, production and proof that the wafer works as promised.

Questions and answers

What is Wafermine?

Wafermine is a small ketamine wafer that dissolves under the tongue. The Defense Department awarded Singapore-based iX Biopharma a nearly $41 million development contract to develop it earlier this year.

Why does the Pentagon want a ketamine wafer?

The wafer is designed to deliver ketamine for acute moderate to severe pain without a needle and without opioids. A 2023 study found ketamine use in battlefield pain care increased between 2010 and 2019 as opioid use decreased.

Can troops get Wafermine before full FDA approval?

The company says it is pursuing an emergency authorization. A September 3 federal emergency use declaration by the Department of Health and Human Services opened the possibility of early authorization for unapproved drugs to treat war wounds.

What is the Nevada license problem?

A Politico investigation found that iX Biopharma's domestic manufacturing partner lacks the Nevada license required to operate. That gap could affect how and where the drug is produced.

Topics: Wafermine, iX Biopharma, Pentagon, ketamine, Food and Drug Administration, battlefield medicine, Pete Hegseth

Sources: Military Times

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