ARMY AL&T
If a Soldier were to breathe in carfentanil unwittingly or get it on their skin, even a freckle-size amount could kill them.
opioids. Tese studies also support FDA fast track designation. Tat status enabled priority review of the new drug application.
Typically, review of an application takes 12 months; however, under priority review, the FDA commits to reviewing the application in six months. In February 2022, six months after submission, the FDA approved the 10 mg naloxone autoinjector new drug application, providing military personnel and chem- ical-incident first responders with a new capability for both the treatment and prophylaxis protection against high-potency opioids.
Using a streamlined acquisition authority, an innovative contract- ing vehicle and enhanced engagements with the FDA, the program team decreased cost and schedule for the development and FDA approval of a 10 mg naloxone autoinjector, and in record time—under four years. Te program team delivered more than one capability, treatment and prophylaxis, with a device that can serve both military and first responders around the world.
MEETING THE DEMAND Even before FDA approval, there was a demand for the 10 mg naloxone autoinjector from specialized units at high risk for opioid exposure. In early 2022, U.S. Special Operations Command requested expedited use of the 10 mg naloxone auto- injector in response to a potential threat overseas.
In March, the assistant secretary of defense for health affairs approved the investigational 10 mg naloxone autoinjector expanded-access protocol, followed shortly by FDA approval. By using already-manufactured product that was excess mate- rial from the development effort, the program team quickly supported the request. Te delivery of the 10 mg naloxone auto- injectors closed two capability gaps: DOD’s urgent need to address weaponized opioid exposure risks and provide access to
https://asc.ar my.mil 75
a lifesaving medical countermeasure to combat exposure to high potency opioids.
CONCLUSION Te Rapid Opioid Countermeasure System provides a “rescue therapeutic” capability for initial treatment at the point of expo- sure, as well as a product that can be used as a prophylaxis. It provides an FDA licensed and approved medical product to support the required attributes necessary for treatment of opioid exposure, and to reverse or significantly mitigate the effects and negative impact of opioid exposure.
With the delivery of the 10 mg naloxone autoinjector, and by promoting research that led to better opioid therapeutics, the program team has increased warfighter readiness, reduced oper- ational risk to potent opioid threat exposure, and taken a major step forward in protecting and maintaining the readiness of the joint force as well as North Atlantic Treaty Organization forces.
For more information, go to
https://www.jpeocbrnd.osd.mil.
ERIK HEINE supports the Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical at Fort Detrick, Maryland. He is a Project Management Professional and holds a bachelor’s degree in business administration from James Madison University.
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