FDA Approves 10-mg Naloxone Injection to Treat Exposure to Ultra-Potent Weaponized Opioids


Kaléo’s product has received fast-track designation for US military personnel facing this threat on the battlefield.

The FDA has approved a naloxone hydrochloride (HCl) injection (Naloxone Auto-injector 10 mg; Kaléo) that is an emergency treatment for individuals who are over aged 12 years where use of high-potency opioids, such as fentanyl analogues as a chemical weapon, is suspected.

Additionally, the naloxone HCl injection is for the temporary prevention of breathing problems, such as respiratory depression, decreased brain and nerve functions, such as central nervous system depression, or both, in military personnel and chemical incident responders entering areas that are contaminated with high-potency opioids, such as fentanyl analogues.

“The Naloxone Auto-injector 10 mg was developed for the JPEO-CBRND’s Rapid Opioid Countermeasure System (ROCS) program and is designed to be a medical countermeasure against the operational exposure of pharmaceutical-based agents, which are highly lethal at very low doses,” Colonel Ryan Eckmeier, manager of the Joint Project for Chemical and Biological Defense Program Medical, said in a statement.

“These synthetic opioids, such as fentanyl and carfentanyl, can pose a devastating threat to our service members. Access to a point of injury countermeasure such as the Naloxone Auto-injector 10 mg is a major step forward to protect and maintain readiness of the Joint Force,” Eckmeier said.

Prototypes of the injection underwent testing and evaluation for suitability on behalf of Chemical, Biological, Radiological, and Nuclear Medical in 2018. The prototypes that were submitted for testing passed all performance criteria, which included 3 cumulative shock tests, 7 cumulative environmental tests, and more than 150 performance verification tests.

Adverse events observed in clinical studies included dizziness, feeling hot, headaches, and injection-site erythema. The precautions and warnings included when administering the injection include precipitation of severe opioid withdrawal and risk of recurrent central nervous system and respiratory depression.

The injection is contraindicated for individuals who are known to be hypersensitive to naloxone HCl or to any of the ingredients.

The injection meets US military standards for use in a broad range of environmental conditions and should be stored at controlled room temperatures of 59ºF to 77ºF, with excursions permitted between 39ºF and 104ºF.

“The most well-known use of weaponized fentanyl occurred in 2002 when Russian forces deployed it against Chechen rebels holding more than 800 people hostage in a Moscow theater,” Glen Kelley, vice president of Development and Regulatory Affairs at Kaléo, said in the statement.

“Today, such weapons could be deployed via drones across wide areas. The Rapid Opioid Countermeasure System is designed to be used not only after exposure to weaponized opioids but can also be used before suspected exposure may occur to temporarily prevent opioid effects,” Kelley said.

The new drug application for Naloxone Auto-injector 10 mg was submitted on August 31, 2021, and was granted fast-track designation by the FDA.


FDA Approves Kaléo’s 10 mg Naloxone Auto-injector for the treatment of known or potential exposure to ultra-potent weaponized opioids. Business Wire. News release. March 2, 2022. Accessed March 3, 2022. https://www.businesswire.com/news/home/20220302005211/en

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