DoD-Supported 10-mg Naloxone Autoinjector Receives FDA Approval to Treat Known or Potential Ultra-Potent Opioid Exposure

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U.S. Army
U.S. Army

April 4, 2022 | Originally published by Joint Program Executive Office for CBRN Defense on April 17, 2022

FORT DETRICK, Md. – On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved a 10-mg naloxone autoinjector designed for nonmedically trained users to protect service members against ultra-potent opioids. It was developed by Kaléo, Inc., in collaboration with the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND’s) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) and the Chemical and Biological Defense Program.

The JPM CBRN Medical’s Rapid Opioid Countermeasure System (ROCS) program has spent nearly three years developing the 10-mg naloxone autoinjector as a rescue treatment to counter pharmaceutical-based agents, which are highly lethal at very low doses. The product is specifically indicated for military and chemical incident responders and can also be used before suspected opioid exposure.

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