Orphan Drug Designation Granted for Treatment after Radiological Disaster
Soligenix announced that the FDA has granted Orphan Drug Designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation (TBI) during or after a radiation disaster. OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), the driving component in early mortality following high doses of TBI. Oral BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.
OrbeShield is formulated as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract. BDP has been marketed as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma since the early 1970s.
For more information call (609) 538-8200 or visit www.soligenix.com.