Mission-Ready Formulation and Needle-Free Delivery System for Protection Against Organophosphorous Chemical Warfare Agents

It is critical that the U.S. Army is mission ready and able to administer a pretreatment dose of butyrlycholinesterase (BChE) to protect soldiers and first responders from organophosphorous chemical warfare agents. Although intravenous and intramuscularymeans are available, they are not practical for delivery of large doses of purified human BChE that are required to protect against nerve agent exposure. The Army has a need to develop a needle-free system for delivering the bioscavenger. Currentneedle-free systems are not available for delivering large quantities of BChE. Foster-Miller proposes an advanced needle-free injector that is practical in battlefield situations. The Phase II program consists of three parts. First, the formulationdevelopment work of Phase I will be expanded to focus on the stability of BChE in both the lyophilized and liquid forms. Secondly a prototype delivery device capable of handling smaller volumes will be developed. Thirdly, the new formulation andprototype device will be integrated and its effectiveness evaluated.Our commercialization partner, an FDA approved supplier of nerve agent antidotes to the DoD and a leader in the medical device industry, has expressed a strong interest in producing the new BChE formulation and the new needle-free delivery device.(P-030475)Developing a practical needle-free method of administering protein-based prophylactics and therapeutic drugs in general would have significant commercial potential. Some specific commercial applications are protecting people from pesticide poisoning,reducing the risk of complications due to cocaine abuse, reversing muscle relaxant-induced apnea following surgery anesthesia, and alleviating symptoms caused by local anesthetics.