FDA approves Naloxone Auto-Injector 10 mg for the treatment of known or potential exposure to ultra-potent weaponized opioids.- Kaleo

Additionally, the Naloxone Auto-injector 10 mg is indicated for the temporary prevention (prophylaxis) of either breathing problems (respiratory depression), decreased brain and nerve function (central nervous system depression), or both, in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

The product was developed for 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) in collaboration with the Chemical and Biological Defense Program (CBDP). The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s CBRN response capability.

“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,” said Colonel Ryan R. Eckmeier, the Joint Project Manager for CBRN Medical. “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.”