Contract includes an initial award for the manufacture and delivery of up to 788,000 ROCS auto-injectors
Richmond, VA (September 21, 2022) Kaléo, a privately held commercial-stage U.S. pharmaceutical company, today announced the execution of the first contract with the U.S. Department of Defense (DoD) for the procurement of the Rapid Opioid Countermeasure System (ROCS), a 10 mg Naloxone Auto-injector (naloxone hydrochloride injection) antidote for ultra-potent weaponized opioids. The contract includes an award for the manufacture and delivery of up to 788,000 units.
“ROCS was developed to protect and maintain the readiness of the Joint Force and our NATO allies,” said Colonel Matthew Clark, PhD, PMP, the Joint Project Manager for CBRN Medical. “Weaponized synthetic opioids, such as fentanyl and carfentanyl, have been used operationally in the past and continue to pose a unique threat to our service members. This first delivery of ROCS auto-injectors is a great achievement.”
Kaléo was awarded the prototype development contract for the ROCS program in 2018 by the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in collaboration with the Chemical and Biological Defense Program (CBDP). The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures (MCM) and systems to enhance the nation’s CBRN response capability.
“This first DoD procurement contract is a major milestone for Kaléo,” said Mark A. Herzog, the company’s vice president, global corporate affairs, defense and homeland security. “We are pleased to have delivered ROCS under budget, and five months ahead of schedule, despite challenges presented by the pandemic and disruptions to the global supply chain.”
Approved by the U.S. Food and Drug Administration (FDA) on February 28, 2022, ROCS is a 10 mg Naloxone Auto-injector (naloxone hydrochloride injection) 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. See full indication below.
Additionally, the Naloxone Auto-injector 10 mg is indicated for the temporary prevention (prophylaxis) of either breathing problems (respiratory depression), 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.
The New Drug Application for the Naloxone Auto-injector 10 mg was submitted on August 31, 2021 and was granted Fast Track Designation by the FDA. In addition to more than 150 performance verification tests, the ROCS Naloxone Auto-injector 10 mg underwent military standard testing and evaluation for suitability on behalf of the JPM CBRN Medical which included three cumulative shock tests and seven cumulative environmental tests. The ROCS Naloxone Auto-injector 10 mg also meets the U.S. Food and Drug Administration (FDA) draft guidance standard for 99.999% device reliability.
For more information about the ROCS program, visit www.naloxoneautoinjector.com.
Kaléo is a fully integrated pharmaceutical company dedicated to inventing, manufacturing and commercializing life-transforming products for certain serious and life-threatening medical conditions. Kaléo’s innovative auto-injection technologies are protected by an extensive intellectual property portfolio of more than 200 issued patents as well as being the first to meet the U.S. Food and Drug Administration (FDA) draft guidance standard for 99.999% device reliability. Kaléo is headquartered in Richmond, Virginia in the United States. For more information, visit www.kaleo.com.
Naloxone Auto-Injector 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.