In the summer of 2022, The DoD’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) awarded a follow-on Other Transaction Authority (OTA) for Production agreement to kaléo, Inc., a nontraditional small business member of the Medical CBRN Defense Consortium (MCDC). 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. Just 30 months after the contract, 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.
The company was previously awarded an OTA in 2019 to develop the 10mg naloxone autoinjectors (NAI) in collaboration with the JPM CBRN Medical and the Chemical and Biological Defense Program (CBDP). With this follow-on OTA, kaléo will manufacture and deliver 10mg NAI as a residual capability to the DoD’s Special User Groups, as well as an emergency stockpile no later than September 2022.
Tasked with delivering a life-saving pharmaceutical to combat opioid exposures, the ROCS team not only delivered a therapeutic, but also a prophylaxis. This lifesaving capability limits the risk of military personnel and first responders becoming non-ambulatory due to opioid exposure. Using innovative strategies and partnering with kaléo, the team accomplished their goals ahead of schedule and under budget, satisfying both demanding DoD acquisition criteria and FDA regulatory processes.
For its impressive efforts, the ROCS product team was selected to receive the 2022 Military Health System Research Symposium award for Outstanding Program Management.
About the Medical CBRN Defense Consortium (MCDC):
MCDC focuses on innovative, safe, and effective medical solutions to counter CBRN threats. MCDC accelerates the Department of Defense’s fielding of prototypes for medical countermeasures to enhance the mission effectiveness of military personnel.