Phase 3 Study Update of Lubiprostone for Opioid-Induced Bowel Dysfunction (OBD)
Sucampo announced positive data from a Phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD).
The Phase 3 trial evaluated lubiprostone for OBD in patients with chronic, non-cancer pain, excluding those taking methadone. As previously announced, in this study lubiprostone met its primary endpoint and was found to be safe and well-tolerated.
Results from this trial not previously disclosed include:
- The proportion of patients with a first spontaneous bowel movement (SBM), at 4, 8, 12, 24 and 48 hours post-dose was found to be statistically significant over placebo (P=0.002, P=0.017, P=0.021, P=0.016 and P=0.022, respectively) with the median time to first SBM being 24.25 hours for those on lubiprostone versus 38.5 hours on placebo (P=0.019).
- Greater proportions of lubiprostone subjects experienced improvement in their OBD symptoms over the 12 week period than did placebo subjects, including: straining associated with SBMs (P=0.002), stool consistency of SBMs (P<0.001), constipation severity (P=0.007), abdominal bloating (P=0.208, not statistically significant) and abdominal discomfort (P=0.048).
- Weekly changes from baseline in SBM frequency (lubiprostone vs. placebo) were significantly different at 8 of the 12 treatment weeks for lubiprostone vs. placebo, with overall statistical significance achieved (P=0.005).
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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