Rafa Laboratories this week announced a new partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services. The goal is to enhance the national preparedness for nerve agent emergencies by developing a new design for Rafa’s pediatric atropine autoinjectors.
Atropine – the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors. Consequently, these medical devices play a crucial role in emergency preparedness and response, as they enable rapid administration of lifesaving treatment.
Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
Rafa’s atropine autoinjectors are widely utilized in military settings. The current device is designed to align with the military practice of pinning a used autoinjector onto clothing using the bent needle. The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories. This includes funding support for advanced development activities, human factor studies, and all regulatory, quality assurance, management, and administrative activities associated with the development of the product. The new autoinjector will offer two dosage strengths based on the patient’s weight, catering to diverse pediatric populations.
Rafa’s newly-designed pediatric autoinjector platform is poised not only to meet the needs of pediatric patients but also to potentially pave the way for needle-protected adult atropine and adult midazolam (for the treatment of Status Epilepticus) autoinjectors, while maintaining an exceptionally high reliability rate of 99.999% successful activation, as required by the FDA for emergency use autoinjectors. These additional developments are included under two options under the contract with BARDA.
The collaboration between BARDA and Rafa Laboratories reflects a shared commitment to developing and improving medical countermeasures to meet emerging global challenges. The newly-designed autoinjector is set to enhance national preparedness, ensuring that civilians will receive life-saving medical treatment promptly and safely in times of crisis.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00055.