Phase 3 Trial Update of Lubiprostone for Opioid-Induced Bowel Dysfunction
Sucampo announced positive top-line results from an open-label Phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.
This trial was a multicenter, open-label extension study designed to evaluate the long-term safety and efficacy of oral lubiprostone given up to 24mcg twice daily as needed for 36 weeks in OBD patients with non-cancer-related pain. All patients in the study had completed one of two preceding (OBD-0631 or OBD-0632) Phase 3 well-controlled efficacy trials of lubiprostone in OBD patients with chronic, non-cancer-related pain. In those randomized, double-blinded trials, patients received placebo or oral lubiprostone 24mcg twice daily for 12 weeks. Baseline assessments during these double-blind trials were also considered as baseline efficacy assessments for the open-label trial. The long-term safety trial treated a total of 439 patients at 116 sites. Patients continued to be treated consistently with opiate therapy during this open-label study. Together with the preceding trials, patients were treated with lubiprostone for up to 48 weeks.
There were no reported serious adverse events that were considered drug-related. Treatment with lubiprostone demonstrated consistent improvements over baseline with respect to bowel frequency rates and other OBD-related symptoms at each timepoint measured throughout the study.
Lubiprostone (marketed as Amitiza by Sucampo and Takeda), is a chloride channel activator currently indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation (IBS-C) in women ≥18 years of age.
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