MEDICAL CHEMICAL DEFENSE (ACD&P)
Abstract
This Project provides for the development of medical materiel and other medical equipment items necessary for the Technology Maturation and Risk Reduction phase of the acquisition life cycle for the advanced development of Medical Countermeasures (MCMs) for chemical warfare agents including diagnostic equipment, prophylactic, pre-treatment, and therapeutic drugs, and individual/casualty decontamination compounds. A family-of-systems approach for medical defense against chemical warfare agents is required to provide protection, to sustain performance in a chemical environment, and to provide for self-aid/buddy-aid and medical treatment of chemical casualties. Fielding of prophylactic, pre-treatment, and therapeutic drugs and medical devices requires Food and Drug Administration (FDA) approval. Given the family-of-systems approach for development of chemical MCMs for the treatment of nerve agent intoxication, multiple long-term studies are required to obtain FDA approval to deliver products that effectively integrate with current and projected therapeutic regimens. Efficacy testing of most candidate drugs against chemical warfare agents cannot be conducted in humans; therefore, animal surrogate models must be developed and employed. The program currently includes: (1) Emerging Threats (EMRT) (2) Improved Nerve Agent Treatment System (INATS) The EMRT program is now called the Rapid Opioid Countermeasure System (ROCS) in FY20 MC5. The ROCS program is conducting the development and fielding of FDA-approved therapeutic medical countermeasures (MCMs). The purpose of the MCM is to provide therapeutic benefits to the Joint Service warfighter against operational exposures to the opioid class of pharmaceutical-based agents (PBAs) as a high priority. The first increment of the ROCS program will develop a naloxone autoinjector as a rescue treatment that will counteract the adverse effects from exposure to opioids. The INATS advanced development provides an enhanced capability treatment regimen offering greater protection over a broader spectrum of toxic nerve agent threats. Components of the development include (1) a new and improved oxime (replacing 2-pralidoxime chloride (2-PAM) to treat current and emerging threats and (2) insertion of a centrally-acting (CA) anticholinergic agent to the treatment regimen to increase survivability and decrease morbidity. Based on recent guidance from the FDA there is no longer a need to expand the pretreatment indications for pyridostigmine bromide (PB) beyond the nerve agent soman. Therefore, the Joint Project Manager for Chemical Defense Pharmaceuticals (JPdM CDP) will execute nonclinical studies to demonstrate the safety of PB when used as a pretreatment should agents other than soman be encountered. The INATS treatment regimen both improves the performance of, and eventually replaces the Antidote Treatment Nerve Agent Auto-injector (ATNAA). The INATS treatment regimen both improves the performance of, and eventually replaces the Antidote Treatment Nerve Agent Auto-injector (ATNAA).
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2020
- Source ID
- MC4_0603884BP_4_0400_PB_2020
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