TD-1211 Phase 2b Study Demonstrates Increased Bowel Movement Frequency in Patients with Opioid-induced Constipation Regardless of Baseline Opioid Dose
Despite their effectiveness, opioids have significant drawbacks, notably the development of analgesic tolerance and physical dependence, sedation, respiratory depression and bowel dysfunction. Opioid-induced constipation (OIC) is common, affecting up to 80% of patients receiving opioids for chronic non-cancer pain.
TD-1211 is an investigational, peripherally selective, multivalent mu-opioid receptor antagonist designed to alleviate gastrointestinal side effects of opioid therapy without affecting analgesia.
Safety and efficacy results, including the primary and key secondary endpoints, from a 5-week, Phase 2b study in chronic non-cancer pain OIC patients have been previously reported.
Since patients with chronic non-cancer pain take a wide range of opioid doses, patients were divided into low and high baseline opioid dose groups (<100 and ≥100 MEU) to explore if baseline opioid dose impacts TD-1211 treatment response.