In an effort to stock up for emergencies involving nerve agents, the Biomedical Advanced Research and Development Authority (BARDA) announced last week it will work with French developer Crossject to gain ZENEO needle-free autoinjectors for the anticonvulsant midazolam.
Midazolam works to treat nerve agent exposure. Such agents – sarin and VX among them – are highly poisonous chemicals that can disrupt the nervous system, causing seizures, respiratory failure, coma, and death. Therefore, time would be of the essence in cases of emergency exposure. Autoinjectors allow rapid and easy response by emergency personnel to help patients.
For this, BARDA turned to authority granted by Project BioShield to fund work at Crossject. Project BioShield is a federally authorized effort to accelerate research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear agents. Autoinjectors created from the partnership will, in turn, go to the CHEMPACK program for storage and distribution at secure locations in local jurisdictions throughout the United States.
Funding will benefit Crossject research studies and late-stage clinical development focused on gaining full regulatory approval for ZENEO midazolam autoinjectors as a drug/device combination product. Procurement would begin after any such device were to receive emergency use authorization (EUA) from the Food and Drug Administration (FDA). After that, Crossject would seek full approval for adult and pediatric populations.