Fast Track Designation Granted for OrbeShield in GI ARS

Soligenix announced today that the FDA has designated its OrbShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of Gastrointestinal Acute Radiation Syndrome (GI ARS), for Fast Track review.

Soligenic has previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death after a potentially lethal dose of total body irradiation during or after a radiation disaster. GI ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the GI tract, and the lungs.

OrbeShield contains BDP, a highly potent, topically active corticosteroid that locally effects inflamed tissue. It is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions off the GI tract. Since the early 1970s, BDP has been marketed in the United States and worldwide as the active pharmaceutical ingredient in inhalation products for the treatment of allergic rhinitis and asthma.

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