MEDICAL CHEMICAL DEFENSE (EMD)

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 the project are: (1) Emerging Threats (EMRT) (2) Alternative Autoinjector (AUTOINJ) (3) Advanced Anticonvulsant System (AAS) (4) Bioscavenger - Plasma (BSCAV-P) (5) The Improved Nerve Agent Treatment System (INATS) The EMRT program is now referred to as the Rapid Opioid Countermeasure System (ROCS) and 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. AUTOINJ 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. The 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. The BSCAV-P is a new capability, to be used as a prophylaxis against nerve agents. 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 effort include (1) a new and improved oxime (replacing 2-pralidoxime chloride (2-PAM) to treat current and emerging threats and 2) the 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 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 pyridostigmine bromide when used as a pretreatment should agents other than soman be encountered. This is no longer a BA5 but BA7 work effort. 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: MC5_0604384BP_5_0400_PB_2020

Tags

Fields of Study

• Medicine

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.
• Neurotoxicology