NEWS | March 17, 2022

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

By Press Release

FORT DETRICK, Md. – On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved a 10mg naloxone autoinjector designed for non-medically 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) 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 10mg 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. 

“Synthetic opioids, such as fentanyl and carfentanyl, can pose a devastating threat to our service members,” said Col. Ryan R. Eckmeier, the Joint Project Manager for CBRN Medical. “Access to a point-of-injury countermeasure such as the 10mg naloxone autoinjector is a major step forward to protect and maintain the readiness of the Joint Force.”

With the newly gained FDA approval, the ROCS program management office plans to deliver the 10mg naloxone autoinjector capability to the Services, and proceed directly into sustainment. Kaléo also continues to work closely with the JPM CBRN Medical to answer NATO forces and other allied nation inquiries for immediate 10mg naloxone autoinjector access.



About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, (JPEO-CBRND) aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. To learn more about the JPM CBRN Medical, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow the JPEO-CBRND on social media at @JPEOCBRND. 

About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. The JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. The JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about the JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow the JPEO-CBRND on social media at @JPEOCBRND.


 

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