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Richmond, Virginia (August 7, 2025) – 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 Michael Wells, Chairman and Chief Executive Officer of Kaléo. “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.
About the Rapid Opioid Countermeasure System (ROCS) (Naloxone HCl Injection, USP)
Approved by the U.S. Food and Drug Administration (FDA) on February 28, 2022, the ROCS is a 10 mg Naloxone Auto-injector (Naloxone HCl Injection, USP) indicated for the emergency treatment of people 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Additionally, the Naloxone Auto-Injector 10 mg is indicated for the temporary prevention (prophylaxis) of either breathing problems (respiratory depression) or 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. See full indication below.
For full labeling and more information about the ROCS program, visit www.naloxoneautoinjector.com.
About The Medical CBRN Defense Consortium
The Medical CBRN Defense Consortium (MCDC) was formed in response to the Government’s expressed interest to establish an Other Transaction Agreement (OTA) with an eligible entity or group of entities, to include industry, academic, and not-for-profit partners, for advanced development efforts to support the Department of Defense’s (DoD) medical pharmaceutical and diagnostic requirements as related to enhancing the mission effectiveness of military personnel.
About Kaléo
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind. Our patented Aerio™ platform, with unmatched capabilities and human factors engineering, powers our portfolio of auto-injector products, as well as products under development for third parties.
Naloxone Auto-Injector INDICATION and IMPORTANT SAFETY INFORMATION
INDICATION
Naloxone Auto-Injector 10 mg is an opioid antagonist indicated for use by military personnel and chemical incident responders for:
IMPORTANT SAFETY INFORMATION
Contraindications – Naloxone Auto-Injector (NAI) 10 mg is contraindicated in individuals with hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NAI 10 mg.
Warnings – Use in patients who are opioid dependent may cause abrupt opioid withdrawal. Use of a product that delivers a dose lower than 10 mg of naloxone HCl may be preferable in treatment of a patient with known opioid dependence.
Precautions – Due to the duration of action of naloxone HCl relative to the opioid, keep the patient under continued surveillance and administer additional naloxone HCl, as necessary, while awaiting emergency medical assistance.
Adverse Events – The following adverse reactions were observed in more than one subject in clinical studies evaluating NAI: dizziness, feeling hot, headache, and injection site erythema.
Please see the full Prescribing Information.
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