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These additional data include the final results of Study 101684, an extension of the Phase 2b Study 008 of alvimopan in cancer pain patients with opioid-induced bowel dysfunction (OBD), further analysis of results from Study 014 and the final study reports from the two-year carcinogenicity studies in rats and mice, which were conducted to support the OBD indication. 5 mg twice daily in patients taking opioids for chronic non-cancer pain and experiencing opioid-induced bowel dysfunction (OBD). The FDA has requested 12-month safety data, including analysis of serious cardiovascular events, from study 767905/014, an ongoing safety study in opioid-induced bowel dysfunction ( |
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