U.S. Food and Drug Administration (FDA) granted Fast Track designation for the Company’s lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhea (IBS-D), announced OrphoMed, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics.
ORP-101 is a metabolically stable, peripherally active partial agonist of the μ opioid receptor and antagonist of the κ opioid receptor that is designed to mitigate colonic hypersensitivity due to intestinal hyperalgesia and associated motility dysfunction in IBS-D.
In multiple clinically relevant animal models ORP-101 has repeatedly been shown to suppress general and colon-specific hyperalgesic signals without CNS penetration and without constriction of the sphincter of Oddi, which could cause acute pancreatitis.
Irritable bowel syndrome (IBS) is the most common functional gastrointestinal (GI) disorder with worldwide prevalence rates ranging generally in the area of 10–15%.Signs and symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
ORP-101 is a proprietary molecule fully owned by OrphoMed without any downstream royalties or associated milestone payments.