Medical Countermeasure Systems (MCS) — Chemical Defense Pharmaceuticals (CDP) consists of the following components:
- Bioscavenger (BSCAV) program is a transformational capability that fills an urgent capability gap in the warfighter’s defense against nerve agents by development of an innovative broad spectrum nerve agent prophylactic that significantly reduces or eliminates the need for post-exposure antidotal therapy to prevent incapacitation and death from nerve agent exposure.
- Advanced Anticonvulsant System (AAS) program will provide an improved intramuscular autoinjector with a faster acting and more effective anti-seizure drug (Midazolam) for treatment after exposure to toxic nerve agent (replaces Convulsant Antidote for Nerve Agents (CANA)). Food and Drug Administration (FDA) approval and initial fielding is expected in FY20.
- Improved Nerve Agent Treatment System (INATS) is an enhanced treatment regimen to counter the effects of nerve agent poisoning. INATS is a two-component program that includes a more effective oxime reactivator to replace 2-pyridine aldoxime methyl chloride (2-PAM), and adds a new centrally acting anticholinergic to the current treatment regimen to increase survival (nerve agent therapeutic; FDA licensure in FY23). A second component to INATS is a centrally acting medical countermeasure designed to treat the nerve agent effects on the central nervous system.
- Rapid Opioid Countermeasures System (ROCS) is a rapid prototype development program for a medical countermeasure against the operational exposure of a broad spectrum of pharmaceutical-based agents, which are highly lethal at very low doses, and of which synthetic opioids (i.e., Fentanyl, Carfentanyl) is a high priority. FDA approval and initial fielding is expected in FY22.
- Medical Radiation Countermeasures (MRADC) is a multilayered suite of products that prevent, diagnose or treat acute radiation syndrome caused by exposure to ionizing radiation.
Strengthening the Industrial Base
- Alternative Autoinjectors Effort (ALT-AI) has multiple efforts focused on identifying and qualifying additional manufacturing sources for autoinjector delivered nerve agent treatments (both developmental and fielded) to expand the industrial base for FDA approved life-saving Soldier-carried autoinjectors. This will better ensure consistent availability of these rescue treatments to the warfighter, U.S. government agencies and international partners.
Legacy Fielded Products
- Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP)is a FDA approved pretreatment drug (Pyridostigmine Bromide) for use when operating under a nerve agent threat environment (for which use of Soman cannot be ruled out) that protects against Soman nerve agent poisoning and must be used with the post-exposure treatments atropine and 2-PAM.
- Convulsant Antidote Nerve Agents (CANA) is a FDA approved intramuscular autoinjector of Diazepam to control seizures after exposure to toxic nerve agent.
- Antidote Treatment Nerve Agent Autoinjector (ATNAA) is a FDA approved intramuscular injection of Atropine and 2-PAM in a single autoinjector for treatment after onset of nerve agent poisoning symptoms.
BENEFIT TO THE SOLDIER
CDP and therapeutics play a critical and strategic role in chemical and biological defense by providing the warfighter with shield-and-sustain capabilities against known or novel threats.
- System attributes established in requirements documentation
- ALT-AI Emergency Use Authorization approved by FDA, allowing emergency use prior to final FDA approval
- INATS-Oxime received verbal concurrence from FDA on a critical parameter needed for Clinical Trial
4QFY17: BSCAV development of manufacturing process compatible with human injectable drug – FDA concurred.
2QFY18: BSCAV manufactured drug in quantities to support Human Clinical Trials
1QFY18: INATS Milestone B
1QFY19: ALT-AI FDA approval for ALT-AI alternative Atropine Autoinjector
4QFY19: INATS-Oxime Milestone B
2QFY20: AAS FDA approval and Initial Operational Capability
3QFY20: INATS-CA Milestone B
FY22: ROCS FDA approval and initial fielding expected
FY23: INATS FDA Licensure expected
2QFY23: AAS Full Operational Capability