Public Health Emergency - Leading a Nation Prepared
BARDA Supports Development of Drugs to Treat Chemical Injury
Two contracts for advanced research and development of drugs to treat injury from exposure to deadly chemical agents were awarded today by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
The contracts, the first by BARDA to address chemical threats, were awarded to Countervail Corp. of Charlotte, N.C., for $5.3 million over 16 months and Southwest Research Institute of San Antonio for $4.4 million over 15 months.
“These contracts represent an important step forward in BARDA’s ongoing efforts to develop medical countermeasures against threats to public health,” said BARDA Director Robin Robinson, Ph.D. “The work completed under these contracts could result in products that help save lives in a chemical threat emergency such as a toxic industrial chemical accident or terrorist attack.”
The contract with Countervail supports advanced development of a drug called galantamine to treat people who have been exposed to organophosphate compounds, which include nerve agents, such as sarin and VX, and pesticides, such as parathion and chlorpyrifos. These chemicals damage nerve endings by inhibiting an enzyme critical to nerve cell electrical signal transmission. The contract includes funding for preliminary efficacy studies for galantamine as a post-exposure treatment for VX.
Galantamine is approved by the U.S. Food and Drug Administration to treat Alzheimer’s disease. The drug also may protect nerve tissues in a chemical bioterrorism attack, helping prevent seizures and degeneration of parts of the brain and nervous system after exposure to chemical agents and potentially filling a gap in the nation’s chemical injury preparedness portfolio. No drug has yet been approved for use after exposure to these chemical agents.
The contract with Southwest Research Institute funds advanced development of a form of a drug called amyl nitrite that can be administered through the nose to treat injuries from exposure to cyanide. While other FDA-approved treatments for cyanide poisoning exist, the existing products must be administered intravenously by medical personnel. A metered-dose nasal spray formulation of amyl nitrite, however, could be administered quickly in the field, keeping affected patients alive until more definitive cyanide treatment can be provided at the hospital.
The contract with Southwest Research Institute will provide the efficacy data necessary to apply for FDA licensure of the drug for cyanide exposure when administered via metered nasal delivery.
BARDA is seeking additional proposals for product candidates that potentially could treat illness and injury from acute and delayed chemical agents, as well as improved diagnostic tools to measure the dose a person has received after a chemical exposure. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN-BAA-11-100-SOL-00009 at www.fbo.gov.
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
For more information about BARDA and the advanced research and development of medical countermeasures, visit www.phe.gov. Contract opportunities and awards are announced at www.fbo.gov.
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
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