Health and Defense Secretaries Facilitate Ketamine Use for Military Emergencies

Initially, the Federal Register notice raised concerns, as the secretaries of health and defense announced a collaboration on emergency use of medical countermeasures for U.S. military personnel, without specifying the rationale.

In July, Defense Secretary Pete Hegseth concluded that a military emergency, or a significant risk of one, existed concerning a heightened threat of chemical, biological, radiological, or nuclear attacks on U.S. forces.

The following month, HHS Secretary Robert F. Kennedy Jr. determined that the circumstances warranted emergency use of a drug targeting moderate‑to‑severe acute pain resulting from such attacks.

Posted on September 3, the notice left many puzzled. A few days later, a press release announced that Singapore‑based iX Biopharma had received approval for an emergency use pathway for its sublingual ketamine product, Wafermine.

Earlier this year, the company secured a $41 million sole‑source contract from the Defense Department under the Trump administration to develop the compound, which partially financed an ongoing phase III trial.

The contract appeared unexpected, according to an unnamed source who described the arrangement as “bizarre.”

Terry Adirim, MD, MPH, MBA, former acting assistant secretary of defense for health affairs, told MedPage Today that the accelerated EUA strategy and sole‑source award merit transparency and scrutiny.

Adirim questioned why the drug required an emergency use pathway before completing the standard phase III studies and approval process, noting that while ketamine itself is well known, this sublingual formulation is novel.

She noted that legitimate operational advantages exist, as sublingual ketamine is easy to carry and needle‑free, making it suitable for large‑scale combat, but emphasized that these reasons must be clearly explained.

She also called for the government to provide justification for the $41 million sole‑source development agreement.

Military sources said the contract was atypical, structured as an Other Transaction Agreement rather than a competitively bid procurement. Although such agreements grant flexibility, federal law still mandates competitive procedures wherever feasible.

It remains unclear whether the notice applies solely to this ketamine product or to other agents as well. Adirim wondered if the heightened risk might be linked to a possible escalation of the Iran war.

A request for comment from HHS remained unanswered at press time.

Ketamine has a lengthy history of battlefield use, and current military guidelines recommend its intravenous, intramuscular, and intranasal forms for significant battlefield pain. Compared with opioids, it causes less respiratory depression and lower blood pressure, which is critical for casualties with hemorrhage, shock, or respiratory compromise.

Adirim noted that this newer sublingual formulation has not been studied as extensively and may require a higher dose due to its metabolism, making the forthcoming phase III results particularly important.

The Federal Register notice does not grant an EUA for sublingual ketamine; it merely creates a pathway for the company to apply for one, Adirim explained. She emphasized that the FDA must still review the application and determine whether it meets statutory standards.

The pathway invoked by Kennedy has limited precedent; the only prior use was in 2018, during the first Trump administration, for freeze‑dried plasma to treat uncontrolled hemorrhage in combat casualties, according to Adirim and iX Biopharma.

The company said in its press release that it intends to submit its EUA application for the sublingual ketamine product by year‑end.

If the EUA is granted, the company will be able to generate revenue ahead of full FDA approval, while continuing its phase III program.

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