May. 20, 2013

TD-1211 Demonstrates a Durable Increase in Bowel Movement Frequency and Return Toward Normal Bowel Function in a 5-Week Phase 2b Opioid Induced Constipation Study


Opioid analgesics such as morphine continue to play a critical role in chronic cancer and non-cancer pain control. 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, 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 (see also APS 2013 Poster #421).

As mu-opioid receptor antagonists can quickly reverse the effects of opioid agonists on gastrointestinal opioid receptors, demonstration of a sustained response on bowel movement frequency is necessary for a therapy intended for patients taking opioids chronically.

Therefore, additional pre-specified week-by-week efficacy analyses are
reported here.

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