Advertisement
Lubiprostone, a chloride channel activator with a novel mechanism ofaction, was developed by Sucampo Pharmaceuticals. The 24-mcg formulation ofthe drug (AMITIZA(R)) is approved for the treatment of Chronic IdiopathicConstipation in adults and is marketed for this indication in the UnitedStates by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America,Inc.
Advertisement
"The FDA's decision to accept our sNDA submission for review is animportant step in filling an unmet medical need for patients with thedebilitating disease of IBS-C," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder,chairman and chief executive officer of Sucampo Pharmaceuticals. "IBS-C has asignificant impact on millions of Americans and, if approved, lubiprostone mayoffer a valuable new treatment option for people living with this condition."
Approximately 58 million Americans have irritable bowel syndrome (IBS),with IBS-C accounting for approximately one-third of these cases. IBS-Csymptoms include abdominal pain and discomfort associated with defecation or achange in bowel habits with features of disordered defecation.
About lubiprostone (8 mcg) and its supplemental New Drug Application
The sNDA, filed with the FDA on June 29, 2007, was based on a clinicalstudy program that included two Phase 3, multi-center, double-blinded,randomized, placebo-controlled trials involving 1,171 adults, followed by onelong-term, open-label safety and efficacy extension trial involving 522 adultsdiagnosed with IBS-C. In the two Phase 3 trials, patients receivedlubiprostone 8 mcg twice daily or placebo twice daily over a 12-week period.Patients receiving lubiprostone were nearly twice as likely to achieve overallrelief that was statistically significant compared to those receiving placebo(17.9% vs. 10.1%; P=0.001). Individually, each study showed lubiprostone'sefficacy over placebo for overall relief (P=0.009 and P=0.031). In thecombined studies, secondary endpoints included abdominal discomfort/pain,stool consistency, straining, constipation severity and quality of life; theseendpoints showed statistically significant improvement in patients receivinglubiprostone vs. placebo. The long-term extension trial demonstrated that theefficacy of lubiprostone continued through the open-label period, withincreasing overall improvement to the end of the 52-week program.
In the two Phase 3 pivotal trials, lubiprostone and placebo groups showeda similar incidence of serious adverse events (1% in both the lubiprostone andplacebo groups) and related adverse events (22% in lubiprostone vs. 21% in theplacebo group). The most common treatment-related adverse events (>5% ofpatients) 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 discomfortor pain is associated with defecation or a change in bowel habit and withfeatures of disordered defecation. IBS is further sub-classified into IBSwith constipation, IBS with diarrhea and mixed IBS, depending upon stoolconsistency. Patients with IBS-C have hard or lumpy stools, but unlikepatients with chronic constipation the frequency of bowel movements is notpart of the diagnostic criteria.
It is the temporal relationship of pain, bowel habit and stoolcharacteristics that is the most prominent feature of IBS-C
