The Department of Defense’s (DoD) Chemical and Biological Defense (CBD) Small Business Innovation Research (SBIR) program awarded CMC Pharmaceuticals an SBIR contract managed by the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) (Contract number: W911SR-22-P-006). The Phase I SBIR award will fund the formulation and analytical development of a multi-dose scopolamine hydrobromide trihydrate vial. The application of this new formulation aims to reduce the logistical burden to military first responders when treating mass exposure to organophosphorus nerve agents (OPNAs).

“The team at CMC Pharma is honored to continue assisting the U.S. Military with the award of this SBIR grant,” said Mike Radomsky, principal investigator and president of CMC Pharma. “We will leverage our medical countermeasure development and scopolamine drug product development experience to help the U.S. military treat and prevent casualties against nerve agent exposure.”

Currently, a single dose scopolamine vial is being developed alongside an autoinjector to provide adjunct therapy for military personnel exposed to nerve agents. However, a multi-dose scopolamine vial would provide a broader range of options in the different military medical care roles. CMC Pharma will complete the chemistry, manufacturing and controls development (formulation, analytical, process and stability studies) of a multi-dose presentation of the scopolamine drug product containing an antimicrobial preservative.

Upon the development of the multi-dose vial, CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain including cGMP manufacturing. CMC Pharma aims to commercialize this drug product for inclusion in the national strategic stockpile.

This program complements CMC’s other medical countermeasure development programs for pre- and post-organophosphate exposure for civilian and military applications.