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). In FY2023, the CBDP RDT&E Projects have been restructured to align to the CBDP portfolio. MC5 efforts in FY2022 progress to the Mitigate (MT5) portfolio. This restructuring is intended to provide standardization and alignment across CBDP research, development and acquisition efforts. Efforts included in this Project are: (1) Advanced Anticonvulsant System (AAS), (2) Alternative Autoinjector Manufacturer Capability (AUTOINJ) **Progresses to MT5 in FY2023**, (3) Improved Nerve Agent Treatment System Centrally Acting (INATS CA) **Progresses to MT5 in FY2023**, and (4) Rapid Opioid Countermeasure System (ROCS) The AAS program provides for 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. In FY23 AAS completes a Phase 1 clinical study from a new manufacturer and submits a New Drug Application (NDA). The AUTOINJ program provides for FDA approved alternative source(s) for autoinjectors that deliver DoD nerve agent antidote and treatment capabilities to the warfighter; thereby mitigating capability fielding and operational readiness risks. This program augments legacy autoinjectors, ATNAA, 2-PAM, and Convulsant Antidote for Nerve Agents (CANA) by providing alternative commercial sources which includes Dual Drug Delivery Device (D4), the Atropine Auto-Injector, and an anti-convulsant autoinjector. The INATS CA program 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. In FY22 INATS CA continues autoinjector development and manufacturing activities of the drug product and autoinjector device, as well as continues non-clinical animal studies. The ROCS program supports the discovery, characterization, development, and fielding of FDA-approved therapeutic Medical Countermeasures (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. The ROCS will be developed using a Middle Tier Acquisition (MTA) approach. In FY22 ROCS completes manufacturing activities, including manufacturing of the drug product and autoinjector device, and completes regulatory activities such as preparation and submission of the New Drug Application (NDA) for approval.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2023
- Source ID
- MC5_0604384BP_5_0400_PB_2023
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) Advanced Anticonvulsant System (AAS)
- Child Accomplishment: 2) Alternative Autoinjector (AUTOINJ)
- Child Accomplishment: 3) Alternative Autoinjector (AUTOINJ)
- Child Accomplishment: 4) AUTOINJ
- Child Accomplishment: 5) AUTOINJ
- Child Accomplishment: 6) AUTOINJ
- Child Accomplishment: 7) Improved Nerve Agent Treatment System Centrally Acting (INATS CA)
- Child Accomplishment: 8) Improved Nerve Agent Treatment System Centrally Acting (INATS CA)
- Child Accomplishment: 9) Improved Nerve Agent Treatment System Centrally Acting (INATS CA)
- Child Accomplishment: 10) Rapid Opioid Countermeasure System (ROCS)
- Child Accomplishment: 11) Rapid Opioid Countermeasure System (ROCS)
- Child Accomplishment: 12) Rapid Opioid Countermeasure System (ROCS)
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