Fort Detrick, Md.  –   On October 04, 2024, the U.S. Food and Drug Administration (FDA) approved Amneal Pharmaceuticals, LLC’s (Amneal) KSHN014 New Drug Application (NDA) for pretreatment protection against chemical agents. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) developed the product with Amneal via the JPM CBRN Medical’s Pyridostigmine Bromide Extended Release (PB ER) program, executed on behalf of the DOD’s Chemical and Biological Defense Program.

The PB ER 105mg tablet is indicated for pretreatment against the lethal effects of Soman nerve agent poisoning in adults, which has been used in chemical warfare. PB ER is formulated in a once-a-day dosage form which can provide extended protection. The current PB pretreatment countermeasure, Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP), requires a three dose-a-day regimen for the pretreatment against Soman. PB ER pretreatment ends at the first sign of nerve agent poisoning, and atropine and pralidoxime therapy starts immediately.   

“Developing and delivering capabilities that promote greater compliance and utilization, especially against deadly nerve agents, is another step forward in protecting the warfighter from the effects of chemical agents we may encounter on the battlefield,” said Col. Matthew Clark, Joint Project Manager for CBRN Medical.

“Strong partnerships and engagement with both the performer and the FDA demonstrate that, together, we can effectively deliver critical medical countermeasures to the warfighter and the nation. FDA approval of this life-saving drug will allow for safe and effective pretreatment of our service members in CBRN-contested environments, and greatly contributes to Joint Force readiness.”
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) mission is to provide integrated layered Chemical, Biological, Radiological, and Nuclear Defense capabilities to the Joint Force across warfighting functions and combined Joint All-Domain Operations. The JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. To learn more about the JPEO-CBRND, visit: https://www.jpeocbrnd.osd.mil/, or follow JPEO-CBRND on social media @JPEOCBRND.
 
About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability.

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