The Pentagon wants ketamine wafers as a battlefield medicine option

The Pentagon wants ketamine wafers. And it seems to want them now.

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

Recently, the drug’s manufacturer announced that it is pursuing an emergency authorization that could make the medication available to troops before it receives full Food and Drug Administration approval, citing a September U.S. declaration of a military emergency that justifies the emergency use of drugs deemed necessary by the Pentagon.

A federal emergency use approval 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.

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.

The notice did not elaborate on the emergency circumstances or state which drugs would be identified for emergency authorization.

A Politico investigation published Tuesday found that iX Biofarma’s domestic manufacturing partner lacks the Nevada license required to operate.

iX Biofarma called the non-opioid medication the “world’s first sublingual ketamine for acute moderate to severe pain,” and said the wafer enables a different delivery mechanism, letting patients absorb the ketamine through the mucous membrane into the bloodstream.

Typically administered via injection, ketamine can alleviate pain, increase euphoria and cause dissociation and amnesia.

A 2023 study found that opioid use to alleviate battlefield injuries decreased between January 2010 and December 2019, while ketamine use increased.

The researchers found 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.”

The company said it received a “sole-source” award for Wafermine development, meaning it did not solicit other vendors.

Eve Sampson is a reporter and former Army officer. She has covered conflict across the world, writing for The New York Times, The Washington Post and The Associated Press.

五角大楼想要氯胺酮片剂。而且似乎现在就想要。

今年早些时候，美国国防部授予新加坡 iX Biopharma 公司一份价值近 4100 万美元的开发合同，用于开发 Wafermine，这是一种装在舌下溶解的小型氯胺酮片剂。

近日，该药物的生产商宣布，他们正在寻求紧急授权，以便在获得美国食品药品监督管理局的全面批准之前，就能让军队使用该药物。他们援引了美国9月份宣布的军事紧急状态，该紧急状态证明五角大楼有权紧急使用其认为必要的药物。

9 月 3 日，美国卫生与公众服务部发布了一项联邦紧急使用批准声明，为提前正式授权打开了可能性，使 FDA 能够使用未经批准的药物来治疗战争创伤。

根据该通知，7 月 15 日，国防部长皮特·赫格塞斯认定“存在军事紧急情况，或存在重大军事紧急情况的可能性，涉及美国军事部队遭受化学、生物、放射性或核制剂袭击的风险增加”，或遭受可能造成危及生命的伤害的制剂袭击。

声明继续说道：“这些袭击造成的伤害可能会导致受害者遭受中度至重度急性疼痛，并使他们面临发生危及生命的血液动力学不稳定的风险，包括休克或呼吸窘迫。”

由于赫格塞斯的决心，卫生与公众服务部部长小罗伯特·肯尼迪宣布，“存在有理由授权紧急使用五角大楼确定的药物的情况”。

该通知没有详细说明紧急情况，也没有说明哪些药物将被确定为紧急授权药物。

Politico 周二发布的一项调查发现，iX Biofarma 的国内生产合作伙伴缺乏在内华达州运营所需的许可证。

iX Biofarma 将这种非阿片类药物称为“世界上第一种用于治疗急性中度至重度疼痛的舌下氯胺酮”，并表示该药片能够实现不同的给药机制，让患者通过粘膜将氯胺酮吸收到血液中。

氯胺酮通常通过注射给药，可以缓解疼痛、增加欣快感，并引起分离和失忆。

2023 年的一项研究发现，2010 年 1 月至 2019 年 12 月期间，用于缓解战场伤情的阿片类药物使用量有所下降，而氯胺酮的使用量则有所上升。

研究人员发现，“氯胺酮通常首先用于伤势较重的患者，并且越来越多地被美国军方用作战斗伤员的主要镇痛药。”

该公司表示，其获得了 Wafermine 开发的“独家”合同，这意味着它没有招标其他供应商。

伊芙·桑普森是一名记者，也是一名前陆军军官。她曾报道过世界各地的冲突，为《纽约时报》、《华盛顿邮报》和美联社撰稿。