Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced the presentation of pooled data from post-hoc analyses of the two pivotal Phase 3 studies of AMITIZA
(lubiprostone) for the treatment of irritable bowel syndrome with constipation (IBS-C) at Digestive Disease Week 2012 in San Diego. This analysis of patients presenting with moderate to very severe abdominal pain and fewer than three weekly spontaneous bowel movements (SBMs) at baseline demonstrates that AMITIZA provides a statistically significantly higher proportion of patients with consistent relief from IBS-C symptoms (greater than 30% improvement from baseline in abdominal pain ratings and normalization of bowel frequency for 9 of the 12 treatment weeks) as compared to placebo treatment.
“IBS-C can be a debilitating and painful disease with a range of abdominal symptoms including abdominal pain, the severity of which has been associated with altered tight junction protein expression and distribution,” commented Ryuji Ueno, M.D., Ph.D., Ph.D., Chair, CEO and CSO of Sucampo and an author of the poster. “The data from this analysis adds to our understanding of AMITIZA, a chloride channel activator, in its role in the treatment of moderate to very severe IBS-C.”
The poster entitled “Patient Response to Lubiprostone for the Treatment of Moderate to Severe Irritable Bowel Syndrome with Constipation (IBS-C),” was authored by Taryn R. Joswick, Fasil Woldegeorgis and Ryuji Ueno, all of Sucampo Pharmaceuticals, Inc.
About the Analysis
Data from two pivotal Phase 3, placebo-controlled, 12-week studies were pooled and post-hoc analyses were conducted to evaluate improvements in subsets of patients with moderate to very severe IBS-C. Patients with documented IBS-C, as defined per Rome II criteria, were randomized in a 2:1 ratio to receive lubiprostone 8-mcg, or placebo, twice daily (BID), for a 12-week treatment period in either of two pivotal, Phase 3, well-controlled studies.
A responder analysis of patients with mean weekly abdominal severity of moderate or worse at baseline and less than 3 SBMs per week demonstrated that a greater proportion of lubiprostone patients (N=199) reported ≥30% improvement form baseline in mean abdominal pain scores, ≥1 SBM per week improvement over baseline and ≥3 SBMs per week compared to placebo (N=119) for 6 of 12 weeks (24.1% vs. 9.2%, p=0.0031) and for 9 of 12 weeks (12.6% vs. 3.4%, p=0.0109). (Note that greater than or equal to 3 SBM’s per week is generally considered to be within the normal range). Lubiprostone was well tolerated throughout the study, with the most common adverse events (greater than 4%) in these patients being nausea (9.3% vs. 5.8%), headache (4.9% vs. 1.7%), and diarrhea (4.4% vs. 1.7%) for lubiprostone vs. placebo, respectively. AMITIZA was well-tolerated in this group of patients as well, with the most common adverse events (greater than 4%) being nausea (9.8% vs. 5.7%), diarrhea (6.7% vs. 4.3%) and upper respiratory infection (4.9% vs. 2.9%) for lubiprostone vs. placebo, respectively.