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FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
Date:9/17/2007

ubiprostone (8 mcg) and its supplemental New Drug Application

The sNDA, filed with the FDA on June 29, 2007, was based on a clinical study program that included two Phase 3, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,171 adults, followed by one long-term, open-label safety and efficacy extension trial involving 522 adults diagnosed with IBS-C. In the two Phase 3 trials, patients received lubiprostone 8 mcg twice daily or placebo twice daily over a 12-week period. Patients receiving lubiprostone were nearly twice as likely to achieve overall relief that was statistically significant compared to those receiving placebo (17.9% vs. 10.1%; P=0.001). Individually, each study showed lubiprostone's efficacy over placebo for overall relief (P=0.009 and P=0.031). In the combined studies, secondary endpoints included abdominal discomfort/pain, stool consistency, straining, constipation severity and quality of life; these endpoints showed statistically significant improvement in patients receiving lubiprostone vs. placebo. The long-term extension trial demonstrated that the efficacy of lubiprostone continued through the open-label period, with increasing overall improvement to the end of the 52-week program.

In the two Phase 3 pivotal trials, lubiprostone and placebo groups showed a similar incidence of serious adverse events (1% in both the lubiprostone and placebo groups) and related adverse events (22% in lubiprostone vs. 21% in the placebo group). The most common treatment-related adverse events (>5% of patients) were nausea (8% vs. 4%, respectively), diarrhea (6% vs. 4%, respectively) and abdominal pain (4% vs. 5%, respectively).

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS is a chronic functional bowel disorder in which abdominal discomfort or pain is associated with defecation or a change in bowel habit and with features of disordered defecation. IBS is further sub-classified into IBS with const
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SOURCE Sucampo Pharmaceuticals, Inc.
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