Kaléo, a global leader in drug-delivery device technology and auto-injector innovation, today announced it received the Prototype Innovation award by the Medical CBRN Defense Consortium (MCDC) in recognition of its successful prototype development of the Rapid Opioid Countermeasure System (ROCS) (Naloxone HCl Injection, USP) antidote for ultra-potent weaponized opioids. This is the first time the MCDC has awarded a stand-out prototype innovation completed under the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Other Transaction Agreement (OTA) contracting vehicle.
The award recognizes groundbreaking innovation and early-stage development efforts that address urgent national security and public health needs through advanced medical countermeasures. The ROCS was initially funded under a prototype development contract awarded in 2019 by the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), part of the U.S. Department of Defense’s JPEO-CBRND in collaboration with the Chemical and Biological Defense Program (CBDP).
“We are honored to receive this recognition for the ROCS antidote, a prototype innovation with the potential to strengthen our nation’s medical countermeasure arsenal,” said Mark Herzog, Kaléo’s Senior Vice President, Global Health Security. “With growing threats from ultra-potent weaponized opioids, the development of the ROCS antidote is important to our nation’s health security. This award affirms the importance of accelerating technologies that can help enhance national preparedness and protect military personnel and chemical incident responders.”
In 2022, the ROCS antidote received U.S. Food and Drug Administration approval and became the subject of the first U.S. Department of Defense supply contract for naloxone specifically designed to address operational exposure to high-potency opioids. As a result of the successful prototype project, this follow-on production agreement was executed for the manufacture and delivery of up to 788,000 auto-injectors.
“The ROCS antidote is an auto-injector designed for use in austere environments, allowing warfighters to treat opioid exposure in non-opioid dependent casualties,” said Kathy Zolman, Advanced Technology International (ATI) Director, Medical Threat and Countermeasures Division. “We are honored to recognize Kaléo and its ROCS antidote as the first Prototype Innovation Award recipient. This recognition underscores the antidote’s important role in enhancing readiness and protecting non-opioid-dependent warfighters against the rising threat of weaponized opioids.”
This is not the first prestigious award bestowed on the ROCS program. In 2022, the ROCS product team also received the Military Health System Research Symposium (MHSRS) award for Outstanding Program Management. MHSRS is the premier military health conference for the U.S. Department of Defense.
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