HHS funds development, purchase of antidote-filled autoinjectors for rapid chemical terrorism response

To speed response to chemical emergencies including acts of terrorism, the U.S. Department of Health and Human Services (HHS) will provide funding and technical expertise to Aktiv Pharma Group of Broomfield, Colorado, for development of an autoinjector to administer a chemical antidote. HHS will purchase the product if the device receives regulatory approval.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response, is using authority under the 2004 Project BioShield Act and $45.3 million in Project BioShield designated funding to support this preparedness effort. The contract has options for additional work, purchase, and delivery of the antidote-filled devices which could total $220 million over seven years.

“Chemical nerve agents can cause life-threatening injury almost immediately, leaving only minutes to save lives," said BARDA Director Gary Disbrow, Ph.D. “Particularly during emergencies involving large numbers of people, emergency responders must be able to administer effective medical countermeasures quickly and easily."

With this support, the company will complete the late-stage development necessary to request U.S. Food and Drug Administration (FDA) approval of the autoinjector containing 2-pyridine aldoxime methyl chloride, also called pralidoxime chloride (2-PAM), to treat organophosphate poisoning in adults and children. Organophosphates are human-made chemicals used as pesticides and, in some parts of the world, as nerve agents in chemical warfare or acts of terrorism.

Organophosphates, such as nerve agents, are highly poisonous chemicals that prevent the nervous system from functioning properly, resulting in respiratory failure, seizures, coma, and potentially death.

The autoinjectors have been designed to improve the ease and speed of administering 2-PAM by emergency medical services (EMS) responders in prehospital settings and by healthcare providers in hospitals during mass casualty incidents involving nerve agents or other organophosphates.

If FDA-approved, the antidote-filled autoinjectors will become part of CHEMPACKs, containers of nerve agent antidotes stored securely in jurisdictions around the country for immediate response to a chemical incident.

The 2-PAM autoinjectors would replace CHEMPACK legacy 2-PAM autoinjectors, complement existing atropine autoinjectors, and complete a comprehensive suite of accessible and easy-to-use emergency treatments for organophosphate chemical exposure.

The autoinjector is based on Aktiv's ARAI platform, utilizing a novel glass-free, collapsible primary drug container (PDC) and is designed to meet the FDA's requirement of 99.999% reliability for emergency use autoinjectors. The ARAI platform is designed to support various dose volumes, simultaneous of multiple drug formulations through separate needles, and automatic reconstitution of drugs formulated in dry form.

The platform was developed over a decade-long partnership between Aktiv, the Department of Defense's Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), and BARDA, and is the latest in BARDA's Portfolio of medical countermeasures – vaccines, treatments and devices – in development or purchased for emergency response.

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