DOR BioPharma ‘s Oral BDP (beclomethasone dipropionate) for the treatment of pediatric Crohn's disease  has been granted Orphan Drug Designation to by the Office of Orphan Products Development of the United States Food and Drug Administration (FDA)

DOR BioPharma, ‘s (DOR) a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR BioPharma, Inc’s  Oral BDP (beclomethasone dipropionate) for the treatment of pediatric Crohn's disease  has been granted Orphan Drug Designation to by the Office of Orphan Products Development of the United States Food and Drug Administration (FDA).The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.

DOR BioPharma, Inc. (DOR) a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.

Oral BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. BDP is also the active ingredient in orBec®, currently in development by DOR for the treatment and prevention of Graft-versus-Host disease (GVHD) is a highly potent, topically active corticosteroid and is the active ingredient in orBec®, DOR's product candidate for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants. Like pediatric Beclomethasone dipropionate Crohn's disease, GI GVHD is also an inflammatory condition of the GI tract. Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea.

In addition to providing a seven year term of market exclusivity for Oral BDP upon final FDA approval, orphan drug designation also positions DOR to be able to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for Oral BDP, and certain tax credits. Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum.