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U.S. Department of Health and Human Services

HHS explores new emergency response use for approved steroid

Drug holds potential to treat gastrointestinal injury from acute radiation syndrome

Date: September 18, 2013
 
Contract company: Soligenix, Inc. of Princeton, N.J.
 
Contract amount: This contract is for two years and approximately $10.6 million contract and can be extended for a total of up to five years and up to $26.3 million.
 
About this contract: Under this contract, the company will continue developing a two-pill system called Orbeshield as a treatment for gastrointestinal acute radiation syndrome.
 
Orbeshield is a corticosteroid known as beclomethasone dipropionate, which is FDA-approved to treat asthma and nasal allergies when used in an inhaler and is the second drug BARDA has added to its portfolio this year for gastrointestinal acute radiation syndrome. Corticosteriods are similar to hormones that the body’s adrenal glands produce to fight stress associated with illnesses and injuries. Corticosteriods reduce inflammation and affect the immune system.
 
One Orbeshield pill would release the drug immediately into the gastrointestinal tract, and the second pill would provide delayed release for a longer effect. Soligenix also will study the drug’s efficacy and how the body absorbs the drug after radiation injury and will optimize a validated commercial-scale manufacturing process.
 
If milestones are met, the company may conduct studies to evaluate potential drug interactions including drugs likely to be used in a radiation emergency, studies on efficacy and to determine doses for adults and children, and other activites supportive of FDA approval.
 
Independently, Soligenix is developing Orbeshield to treat more common illnesses, such as pediatric Crohn’s disease and graft-versus-host-disease in which the body’s cells attack transplanted cells.
 
Currently no products are approved by the U.S. Food and Drug Administration to treat injury to the gastrointestinal system caused by exposure to high doses of radiation which could occur after the detonation of a nuclear bomb or improvised nuclear device.
 
The project is part of an ongoing effort by BARDA to develop new medical drugs and products to protect health and safety during a radiological or nuclear emergency.
 

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  • This page last reviewed: April 28, 2017