
五角大楼迫切需要这种含有氯胺酮成分的药片,而且似乎现在就急需这些药片。
The Pentagon wants ketamine wafers.
今年早些时候,美国国防部向总部位于新加坡的 iX Biopharma 公司授予了一份价值近 4100 万美元的开发合同,要求该公司研发一种名为 “Wafermine” 的药物——这种药片体积小巧,内含氯胺酮成分,使用时只需将其放在舌下即可溶解。
And it seems to want them now.
最近,该药物的制造商宣布正在申请紧急使用授权,以便在获得美国食品药品监督管理局(FDA)的正式批准之前就将这种药物提供给军队使用。他们援引了美国政府在 9 月份发布的“军事紧急状态”声明作为依据,认为这种药物属于 Pentagon 判断为“必要”的应急用药。
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.
美国卫生与公众服务部于 9 月 3 日发布的紧急使用授权声明为提前批准该药物的使用提供了可能,使 FDA 获得了在战场上使用未经批准药物的权限。
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.
根据该声明,国防部长皮特·赫格塞思(Pete Hegseth)于 7 月 15 日认定:“美国军队面临严重的军事紧急威胁,这种威胁可能来自化学、生物、放射性或核武器攻击,或者可能导致致命伤害的攻击。”声明还指出:“这些攻击造成的伤害可能导致军队成员出现中度至重度的急性疼痛,并使他们面临生命危险的血液动力学不稳定(如休克或呼吸窘迫)。”
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.”
基于赫格塞思的这一判断,卫生与公众服务部部长小罗伯特·肯尼迪(Robert Kennedy, Jr.)宣布:“当前的情况确实证明了批准 Pentagon 指定的药物用于紧急情况的必要性。”
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.
不过,该声明并未详细说明具体的紧急情况,也未明确哪些药物将被批准用于紧急使用。
The notice did not elaborate on the emergency circumstances or state which drugs would be identified for emergency authorization.
《Politico》杂志周二发布的调查显示,iX Biopharma 公司的国内生产合作伙伴并未具备在 Nevada 州开展生产活动所需的许可证。
A Politico investigation published Tuesday found that iX Biofarma’s domestic manufacturing partner lacks the Nevada license required to operate.
iX Biofarma 称这种非阿片类药物为“全球首款用于治疗急性中重度疼痛的舌下含服氯胺酮”,并表示这种薄片采用了不同的给药机制,让患者通过口腔黏膜将氯胺酮吸收进入血液。
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.
通常通过注射给药的氯胺酮能够缓解疼痛、产生欣快感,并导致解离和遗忘。
Typically administered via injection, ketamine can alleviate pain, increase euphoria and cause dissociation and amnesia.
一项 2023 年的研究发现,在 2010 年 1 月至 2019 年 12 月期间,用于缓解战场伤痛的阿片类药物使用量下降,而氯胺酮使用量上升。
A 2023 study found that opioid use to alleviate battlefield injuries decreased between January 2010 and December 2019, while ketamine use increased.
研究人员发现,“氯胺酮通常首先用于伤情更严重的患者,并越来越多地被美军作为战斗伤员的主要镇痛药使用。”该公司表示,它获得了 Wafermine 开发的“单一来源”合同,意味着无需征询其他供应商。
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.