Public Health Emergency - Leading a Nation Prepared
The first intranasal (nose spray) treatment for the life-threatening effects of cyanide poisoning will be developed under an agreement between the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Emergent BioSolutions of Gaithersburg, Maryland. Cyanide could be used as a chemical weapon against the United States.
“Cyanide is easily obtained, and exposure to high levels of the chemical can cause death within minutes,” explained Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR. “All currently approved cyanide antidotes are administered intravenously, which takes time, training, and medical resources. To save lives, first responders need a treatment they can administer easily within seconds in the field.”
Under the 17-month, $12.7 million agreement announced today, Emergent will develop an intranasal, stabilized form of Isoamyl Nitrite. Amyl Nitrite traditionally has been used to treat angina pectoris, severe chest pain caused by an inadequate supply of oxygen-rich blood to the heart.
Studies have shown Amyl Nitrite to be an effective treatment for cyanide poisoning, although the drug is not approved by the U.S. Food and Drug Administration specifically for this use. The company will develop a reformulated active ingredient, isoamyl nitrite, along with an intranasal delivery device, with the goal of gaining FDA approval. The contract can be extended up to a total of approximately $63 million over 5 years.
As a BARDA partner, Emergent will conduct nonclinical and clinical safety and efficacy studies; manufacturing activities; all associated regulatory, quality assurance, management work, and administrative activities necessary prior to the initiation of a Phase 3 (large) clinical study.
Development of this new drug is part of BARDA’s efforts to develop medical products and procedures to protect health and save lives in terrorist attacks, including those using chemical warfare agents like cyanide. Cyanide was used in World War I as a chemical weapon, in World War II concentration camps, and most recently this past spring in the Syrian Civil War.
These treatments are among the post-exposure treatments and non-pharmaceutical interventions BARDA and its private partners are developing to counter the health effects of chemical exposure. Products include novel and repurposed therapeutics, and decontamination for treatment of exposure to any of four classes of chemical agents.
BARDA continues to seek proposals for the development of effective products to treat injuries caused by chemical agents, including new products and 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.
The project announced today is part of BARDA’s integrated portfolio for the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. For more information about advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov.
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