A close up of the naloxone 10mg autoinjector device
1 / 2 Show Caption + Hide Caption – The naloxone 10mg autoinjector device now available through DLA. (Photo Credit: Photo courtesy of Kaleo) VIEW ORIGINAL
ROCS NAI
2 / 2 Show Caption + Hide Caption – A service member practices administering the high-dose naloxone autoinjector (NAI) as a rescue treatment to counter opioid poisoning. The NAI is a pre-filled autoinjector containing 10 milligrams of the opioid antagonist naloxone and can be administered via self- or buddy-aid into the front or side of the thigh through clothing, even chemical protection gear such as Mission Oriented Protective Posture suit. (Photo Credit: Photo courtesy of Kaleo) VIEW ORIGINAL

FORT DETRICK, MD  –   Long approved for pain control in civilian and military medicine, synthetic opioids are substances that are created in a laboratory and act on the same targets in the brain as natural opiates like morphine and codeine. However, while developed with the best of intentions for pain relief, synthetic opioids such as fentanyl and carfentanil are also currently the main cause of drug overdose deaths in the United States. Ultra-potent versions of synthetic opioids are also believed to have been utilized by Russian special forces to incapacitate Chechen terrorists during a hostage rescue in the Dubrovka theatre in Moscow in 2002, resulting in the death of 127 hostages from the opioid exposure. The possibility of these being utilized as chemical weapons by terrorists or within the chemical, biological, radiological, and nuclear (CBRN) battlespace is very real. In the event of an ultra-potent opioid attack, commercial off-the-shelf treatments require multiple doses, and the response presents challenges to emergency personnel in chemical protective gear. But hope is on the horizon and a lifesaving product to combat ultra-potent opioid exposure is now readily available to warfighters and emergency responders with the click of a mouse.

Tasked with delivering a lifesaving pharmaceutical to service members who may be exposed to ultra-potent opioids, the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical’s (JPM CBRN Medical) Rapid Opioid Countermeasure System (ROCS) program, through partnership with kaléo, Inc., and with funding from the Chemical and Biological Defense Program (CBDP), developed and delivered a high-dose naloxone autoinjector (NAI) as a rescue treatment to counter opioid poisoning in less than three years. This NAI is a pre-filled autoinjector containing 10 milligrams of the opioid antagonist naloxone and can be administered via self- or buddy-aid into the front or side of the thigh through clothing, even chemical protection gear such as Mission Oriented Protective Posture, or “MOPP.” The JPM CBRN Medical is a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).

On February 28, 2022, the U.S. Food and Drug Administration approved the 10-milligram NAI for use by military personnel and chemical incident responders for two uses: the first for the emergency treatment of individuals 12 years and older for suspected use of high potency opioids, such as fentanyl analogues as a chemical weapon, and the second as a temporary prevention against respiratory depression, central nervous system depression, or both in military personnel and chemical incident responders entering an area contaminated with high-potency opioids.

To then bring this critical capability to the Services, the JPM CBRN Medical logistics team, in collaboration with the DLA Troop Support (TS), worked diligently to add the NAI to the DLA’s Pharmaceutical Prime Vendor Program (PPV). The PPV program is an innovative contract method used to provide drugs and other pharmaceuticals to our nations and Veterans, and other federal Government agencies. It is a concept of support whereby a prime commercial distributor serves as the provider of a broad range of drugs and pharmaceuticals, providing drugs directly to the customer and eliminating the need for managing large inventories at military facilities.

On June 01, 2023, a Distribution and Pricing Agreement (DAPA) was awarded to MacleanRx, facilitating addition of the 10mg NAI to the PPV program and allowing immediate availability to the Joint Services with deployed units to rapidly acquire as needed via National Stock Number (NSN) 6505-01-699-8878. For more information about the PPV program, visit: https://www.medical.dla.mil/Portal/PrimeVendor/PvPharm/PharmPVOverview.aspx.

“Convenient access to this lifesaving product is critical for operational readiness for service members, first responders like police, firefighters, and EMS, and border patrol at risk to ultra-potent opioid exposure,” said Joint Project Manager for CBRN Medical Col. Matthew Clark. “Of course, the hope is that this capability will never be needed on or off the battlefield, but its availability in the PPV program will ensure that we have the capability, if and when we need it, allowing us to effectively combat CBRN threats.”

Delivery of this fast-acting opioid therapeutic increases warfighter readiness, supports Defense Support to Civil Authorities across the homeland, and reduces operational risk to potent opioid exposure. Access to a point-of-injury countermeasure like the 10-milligram NAI is a major step forward to protect and maintain the readiness of the Joint Force while also supporting all who serve Americans across the country and around the world.