In 2019, Kaléo was selected by the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) to develop a 10 mg naloxone hydrochloride auto-injector for non-medically trained users to protect American service members against weaponized ultra-potent opioids.
The Food and Drug Administration granted priority review for this product and approved the New Drug Application on February 28, 2022.
Known by the U.S. Department of Defense as the Rapid Opioid Countermeasure System (ROCS), the product is specifically designed as a rescue treatment to counter pharmaceutical-based agents, which are highly lethal at very low doses.
– COL Ryan R. Eckmeier
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.READ ORIGINAL ARTICLE
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