Postive results from Phase III analysis of Amitiza (Sucampo) for IBS-C

A post-hoc analyses of two pivotal Phase III studies of Amitiza (lubiprostone), from Sucampo, for the treatment of Irritable Bowel Syndrome with constipation (IBS-C) demonstrates that the drug provides a statistically significantly higher proportion of patients with consistent relief from IBS-C symptoms compared to placebo treatment. Patients with documented IBS-C, as defined per Rome II criteria, were randomized in a 2:1 ratio to receive Amitiza 8-mcg, or placebo, twice daily (BID), for a 12-week treatment period in either of two pivotal Phase III controlled studies. Results show that patients taking Amitiza showed greater than 30% improvement from baseline in abdominal pain ratings and normalization of bowel frequency for 9 of the 12 treatment weeks. 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. The drug was approved for the treatment of IBS-C in women 18 yrs of age and older by the FDA in 2008. Results were presented at Digestive Disease Week 2012 in San Diego.