Public Health Emergency - Leading a Nation Prepared
To prepare for radiological and nuclear emergencies, the U.S. Department of Health and Human Services (HHS) will work with Argentum Medical, LLC of Geneva, Illinois, to repurpose its commercial product Silverlon for radiation injuries of the skin.
Silverlon is a product that has been cleared by the U.S. Food and Drug Administration as a burn and wound trauma dressing. This contract will look at the potential use of Silverlon for use for low-grade and severe skin radiation injuries after a radiation emergency.
The development work will be done under a three-year, $8.4 million contract between Argentum and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).
“One danger of radiation exposure that many people do not think about is damage to the skin, which can range from mild to potentially life threatening,“ said BARDA Director Rick Bright, Ph.D. “As we work to strengthen our nation’s security against radiological weapons, repurposing commercially available products has many advantages to protect the public from radiation injuries.”
Commercially available products that are familiar to medical providers and patients will potentially increase their willingness to use the products. The products also may be readily available in hospitals, ambulances, and other health care facilities, making them quickly accessible during a mass-casualty incident. This availability reduces the need for government stockpiles which minimizes the cost to taxpayers.
While the severity of radiological and nuclear weapon-related skin injury varies, low-grade skin injuries tend to be similar The low-grade skin injury caused by radiological or nuclear weapons is similar to a skin injury called radiation dermatitis (RD) that can be seen as a side effect radiation therapy. Because of this similarity, FDA provided guidance on a streamlined methodology to apply for clearance of the product.
With FDA guidance, a two-pronged approach was developed. A pathway appropriate for a radiation-injury indication covering the symptoms of erythema, such as skin redness and irritation and dry desquamation, where the skin appears broken or cracked. The second approach requires animal studies to demonstrate mitigation of more severe radiation injuries typically not seen in RD cases.
Under a separate contract with BARDA, Argentum is nearing completion of studies required to apply for FDA clearance of Silverlon for skin burns caused by sulfur mustard chemical weapon exposure.
BARDA continues to seek products to prevent, treat or manage injuries caused by chemical, biological, radiological or nuclear agents in a mass casualty emergency. Proposals are accepted through Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.
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.
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.
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