The U.S. Food and Drug Administration (FDA) recently granted orphan drug status to AST-120, made by Ocera Therapeutics (http://www.oceratherapeutics.com) , for the treatment of pouchitis.
AST-120 is an oral agent which absorbs bile acids and bacterial toxins, and mediates inflammation in the gastrointestinal tract. It is currently being evaluated in a Phase 2 clinical trial in patients with active pouchitis.
Less than 100,000 patients in the United States suffer from pouchitis, which qualifies AST-120 for Orphan Drug status in this condition.
Orphan Drug status was created by the FDA to encourage companies to develop medicines for the treatment of rare diseases, by providing developers with market exclusivity of their products for seven years, in addition to other incentives.
You may want to contact the company, to find out if you qualify for the Phase 2 pouchitis AST-120 clinical trial. Though not listed, specifically, under "Clinical Trials," it is mentioned elsewhere on their web site.
Ocera Therapeutics, Inc.12651 High Bluff Drive, Suite 230San Diego, CA, 92130
Office Tel: 858-436-3900Office Fax: 858-436-3999
email: ashibata@ocerainc.com
www.oceratherapeutics.com