MEDICAL CHEMICAL DEFENSE (EMD)
Abstract
This project provides for the development of medical materiel and other medical equipment items necessary to provide an effective capability for medical defense against chemical warfare agent threats facing U.S. forces in the field. This project supports efforts in the Engineering and Manufacturing Development (EMD) phase of the acquisition strategy for prophylactic, pre-treatment, and therapeutic drugs and diagnostic medical devices for the protection, treatment, detection, and medical management of chemical warfare agent exposures. Project provides for the research and development of safety studies, manufacturing scale-up, process validation, drug interaction, performance test, and submission of the Food and Drug Administration (FDA) drug licensure application(s). This program currently includes: (1) Alternative Autoinjector (AUTOINJ), which consists of investigating an FDA approved alternative source(s), beyond the single current DoD source, for autoinjectors that deliver DoD nerve agent antidote and treatment capabilities to the warfighter; mitigates capability fielding and operational readiness risks. This resulted from the manufacturing and quality issues for the fielded ATNAA product, the oxime (2-PAM) and atropine in a dual chambered autoinjector. (2) The Advanced Anticonvulsant System (AAS), consists of Midazolam in an autoinjector for treatment of nerve agent induced seizures. Midazolam, injected intramuscularly, will treat traditional nerve agent and non-traditional agent-induced seizures and prevent subsequent neurological damage. Midazolam is more water-soluble than diazepam (the currently fielded medication to control nerve agent-induced seizures) and terminates nerve agent-induced seizures more quickly than diazepam. AAS will not eliminate the need for other protective and therapeutic systems; (3) Bioscavenger - Plasma (BSCAV-P), a new capability, to be used as a prophylaxis against nerve agents; (4) Improved Nerve Agent Treatment System (INATS) an enhanced chemical warfare nerve agent treatment regimen consisting of an improved oxime to replace the current fielded oxime 2-pralidoxime chloride (2-PAM), a centrally acting therapeutic to increase survival, and non-clinical studies to demonstrate the safety of pyridostigmine bromide (PB) as a pretreatment for nerve agents in addition to soman.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2019
- Source ID
- MC5_0604384BP_5_0400_PB_2019
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- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
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- Child Accomplishment: 3) AUTOINJ
- Child Accomplishment: 4) AUTOINJ
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