FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D

News | 04. 25. 2018


San Francisco, CA, April 25, 2018 – OrphoMed, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies aimed at treating serious conditions and addressing unmet medical needs. This designation allows early and frequent communications between the FDA and the company sponsor throughout the drug development and review process. Additionally, Fast Track designated drugs are eligible for priority review, which can expedite the FDA's review of a New Drug Application (NDA).