Sucampo (SCMP) Says AMITIZA Had Statistically Significant Results Following Two Phase 3s
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Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) presents 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.
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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.
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