Posted by Michael Wonder on 26 Apr 2018
FDA grants fast track designation for OrphoMed’s ORP-101 for treatment of IBS-D
25 April 2018 - OrphoMed announced today that the U.S. FDA has granted fast track designation for the Company’s lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhoea.
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 irritable bowel syndrome with diarrhoea. 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.
