Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced the presentation of positive data from a Phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD), at Digestive Disease Week 2012, held in San Diego, California . 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.
“We believe that these data demonstrate that lubiprostone may represent an important new treatment option for patients suffering from this condition,” said M. Mazen Jamal, M.D., M.P.H., a lead investigator in the trial and Chief of Endoscopy, Long Beach Veterans Affairs’ Medical Center, Long Beach, California, Professor, Department of Medicine, University of California College of Medicine at Irvine. Dr. Jamal gave the presentation, entitled “ Lubiprostone improves treatment response in opioid-induced bowel dysfunction patients with chronic, non-cancer pain: results from a Phase 3, randomized, double-blind, placebo-controlled clinical trial.”
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).
There were no drug-related serious adverse events reported for patients taking lubiprostone. Overall, the percentage of patients discontinuing treatment due to adverse events was 5.0% for the lubiprostone group compared with 1.8% in the placebo group. Of the patients receiving lubiprostone, 23.5% discontinued the study versus 18.6% of patients on placebo. The most common treatment-related adverse events (experienced by >5 percent of patients) were diarrhea (9.6% vs. 1.4%), nausea (8.2% vs. 2.7%), and abdominal pain (5.5% vs. 0.0%) for lubiprostone vs. placebo, respectively. A majority (91.7%) of lubiprostone patients who reported diarrhea described the events as mild to moderate in severity. The incidence rates of severe nausea were 1.4% for placebo-treated patients and 0.9% for lubiprostone treated patients.About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C) AMITIZA is a chloride channel activator indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older.