Medical Chemical Defense (SDD)
Abstract
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. This 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). Efforts included in this project are: (1) Advanced Anticonvulsant System (AAS), (2) Alternative Autoinjector Manufacturer Capability (AUTOINJ), (3) Bioscavenger (BSCAV-P), (4) Improved Nerve Agent Treatment System (INATS), (5) Improved Nerve Agent Treatment System Centrally Acting (INATS CA), and (6) Rapid Opioid Countermeasure System (ROCS) 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. AUTOINJ consists of investigating an FDA approved alternative source(s), beyond the single current Department of Defense (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 Antidote Treatment Nerve Agent Auto-injector (ATNAA) product, the oxime (2-PAM) and atropine in a dual chambered autoinjector. This program augments legacy autoinjectors, ATNAA, 2-PAM, and CANA by providing alternative commercial sources which include Dual Drug Delivery Device (D4), the atropine autoinjector, and anti-convulsant autoinjector. BSCAV-P was intended to be a new capability for use as a prophylaxis against nerve agents. This program is pursuing closeout activities during FY19 and FY20. INATS Pre-Breakout advanced development in FY19 and FY20 provides an enhanced capability treatment regimen offering greater protection over a broader spectrum of toxic nerve agent threats. The development includes insertion of a CA anticholinergic agent to the treatment regimen to increase survivability and decrease morbidity. The INATS treatment regimen both improves the performance of, and eventually replaces the Antidote Treatment Nerve Agent Auto-injector (ATNAA). INATS CA advanced development in FY21 provides a centrally-acting anticholinergic agent to increase survivability and decrease morbidity after exposure to toxic nerve agent threats. Scopolamine was selected for development after an extensive analysis of alternatives and review of data by the Science and Technology community. Added to the currently fielded system, the INATS CA program will improve overall medical outcomes and will be utilized as both a vial for use at definitive care and a stand-alone auto-injector for use in the field. ROCS is specifically supporting the discovery, characterization, development, and fielding of FDA-approved therapeutic MCMs to protect the Joint Service warfighter against operational exposures to the opioid class of pharmaceutical-based agents (PBAs), 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.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2021
- Source ID
- MC5_0604384BP_5_0400_PB_2021
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) Advanced Anticonvulsant System (AAS)
- Child Accomplishment: 2) Alternative Autoinjector Manufacturer Capability (AUTOINJ)
- Child Accomplishment: 3) AUTOINJ
- Child Accomplishment: 4) AUTOINJ
- Child Accomplishment: 5) AUTOINJ
- Child Accomplishment: 6) AUTOINJ
- Child Accomplishment: 7) Bioscavenger (BSCAV-P)
- Child Accomplishment: 8) Improved Nerve Agent Treatment System (INATS)
- Child Accomplishment: 9) Improved Nerve Agent Treatment System Centrally Acting (INATS CA)
- Child Accomplishment: 10) INATS - CA
- Child Accomplishment: 11) Rapid Opioid Countermeasure System (ROCS)
- Child Accomplishment: 12) Rapid Opioid Countermeasure System (ROCS)
- Child Accomplishment: 13) Rapid Opioid Countermeasure System (ROCS)
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