The Food and Drug Administration (FDA) has approved Naloxone Auto-Injector 10mg (naloxone hydrochloride injection) for use by military personnel and chemical incident responders for the emergency treatment of individuals 12 years of age and older where use of high potency opioids such as fentanyl analogues as a chemical weapon is suspected.

Naloxone Auto-Injector is also indicated for temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high potency opioids such as fentanyl analogues.

The product is specifically designed to be a medical countermeasure for military personnel or chemical incident responders against the potential threat of exposure to synthetic opioids on the battlefield. It was developed for the JPEO-CBRND’s (Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense) Rapid Opioid Countermeasure System (ROCS) program.

The Naloxone Auto-Injector 10mg meets the US military standards (MIL-STD-810H) for use in a broad range of environmental conditions. 

“Kaléo was selected by the Department of Defense to design and manufacture the Rapid Opioid Countermeasure System for military personnel and chemical incident responders. […],” said Ron Gunn, President and CEO of Kaléo. “In addition, we are working closely with the JPM CBRN Medical to support the inquiries from NATO forces and other allied nations for immediate access to the Naloxone Auto-injector 10mg.”


FDA approves Kaléo’s 10 mg Naloxone Auto-Injector for the treatment of known or potential exposure to ultra-potent weaponized opioids. News release. Kaléo. Accessed March 2, 2022.