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news.Sucampo Pharmaceuticals has presented positive data from a Phase III trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD).
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In the study, which estimated Amitiza (lubiprostone) for OBD in patients with chronic, non-cancer pain, excluding those taking methadone, the investigation compound met its primary endpoint and was found to be safe and well-tolerated.
The study reported that 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 significant over placebo with the median time to first SBM being 24.25 hours for those on lubiprostone versus 38.5 hours on placebo.
Most of the lubiprostone subjects experienced improvement in their OBD symptoms over the 12 week period than did placebo subjects.
Amitiza is a chloride channel activator indicated for the treatment of CIC (24mcg twice daily) in adults and for IBS-C (8mcg twice daily) in women 18 years of age and older.