The Medical CBRN Defense Consortium (MCDC) has presented a Prototype Innovation Award to Kaléo for the development of the Rapid Opioid Countermeasure System (ROCS), a 10 mg naloxone hydrochloride auto-injector designed to counteract exposure to ultra-potent weaponized opioids. The award recognizes outstanding early-stage development efforts that directly support national defense and public health priorities.
The ROCS program, funded through a 2019 prototype contract by the U.S. Department of Defense’s Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), was executed under the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) and its Other Transaction Agreement (OTA) mechanism. The initiative has been carried out in collaboration with the Chemical and Biological Defense Program (CBDP).
Kaléo’s ROCS device was approved by the U.S. Food and Drug Administration (FDA) in 2022. Following this milestone, the company entered into a follow-on production agreement to manufacture and deliver up to 788,000 units to support operational use by U.S. military personnel and chemical incident responders.
Operational Utility and Threat Landscape
ROCS was developed to provide immediate treatment and short-term prophylaxis for individuals exposed to high-potency opioids—including synthetic fentanyl analogues—that may be deployed as chemical weapons. Designed specifically for use in austere environments, the device enables responders and non-opioid-dependent warfighters to administer life-saving treatment during emergencies.
“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, Director of the Medical Threat and Countermeasures Division at Advanced Technology International (ATI), which manages the MCDC OTA. She emphasized the award’s role in highlighting the device’s operational relevance amid growing chemical threats.
Mark Herzog, Senior Vice President of Global Health Security at Kaléo, noted that the award underscores the urgent need to develop and field novel technologies to mitigate the national security risks posed by weaponized opioids. “This award affirms the importance of accelerating technologies that can help enhance national preparedness and protect military personnel and chemical incident responders,” he said.
Background and Recognition
The ROCS device marks the first naloxone auto-injector specifically approved and contracted by the U.S. Department of Defense for high-threat operational environments. It is indicated for emergency use in individuals 12 years and older when exposure to ultra-potent opioids is suspected, as well as for temporary prophylaxis in responders operating in contaminated zones.
In addition to the MCDC recognition, the ROCS program team received the Military Health System Research Symposium (MHSRS) award for Outstanding Program Management in 2022.
For additional details on the ROCS program and prescribing information, visit naloxoneautoinjector.com.