(Released 25 June 2018) One of the drugs stockpiled by the U.S. government to save lives from chemical nerve agents needs a new auto-injector so the drug can be used quickly and safely without specialized training if an attack occurs in the United States. The U.S. Department of Health and Human Services (HHS) will work with AktiVax, Inc., of Boulder, Colorado, on developing a new device to easily administer a drug that reverses damage inflicted by organophospates, a class of chemicals that include nerve agents such as Sarin and VX.
“Chemical agents can kill within hours,” said Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “To save lives, we need products at the ready that allow local first responders to act immediately.”
Organophospates damage the enzymes that control the human nervous system. The results include paralyzing muscles needed to breathe, damage to parts of the brain that control breathing, and uncontrollable seizures. Together these effects can lead rapidly to death. U.S. health security measures include stockpiling nerve agent antidotes such as 2-PAM, pralidoxime chloride, to combat these effects.
2-PAM is administered using an auto-injector. Auto-injectors are prefilled, pen-style drug delivery devices commonly used to administer lifesaving medication to people experiencing severe allergic reactions, or by diabetics for insulin shots. Auto-injectors for 2-PAM are no longer manufactured and were originally designed for military use.
Under an 18-month, $15 million contract with BARDA, AktiVax will advance the development of its ARAI platform technology, combining the ARAI auto-injector with the drug 2-PAM to create ARAI-2PAM. The contract can be extended up to a total of $55 million over four years and could support putting other medications into the ARAI platform.
The ARAI platform technology has the potential to be used for administering drugs other than 2-PAMor for administering multiple drugs at once to adults or children and is designed with modern technology that can be used safely by members of the public.
Development of the new device also could diversify the supply chain for auto-injectors to administer drugs in the HHS Strategic National Stockpile.
BARDA continues to seek proposals for development of effective products to treat injuries caused by chemical agents, including new products or new indications for products already in clinical use. The products must be easy to use in a mass casualty situation and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN-BAA-16-100-SOL-00001 at the Federal Business Opportunities website, www.fbo.gov.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
Based in Boulder Colorado, AktiVax Inc. is a Specialty Pharmaceutical company developing drug products in a proprietary portfolio of glass-free prefilled drug delivery devices. The company is employing a user centric design approach to improve usability, drug stability, and streamline medical procedures. The ARAI auto-injector platform is designed to improve usability, by minimizing training and preventing prevalent usability errors; improve drug stability; and improve robustness, to provide people at risk, and their communities, peace-of-mind that a lifesaving treatment will be delivered when and where needed.
For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit www.medicalcountermeasures.gov.
Released by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Click here for source.