Sucampo Pharmaceuticals, Inc announced results of its phase-2b dose-ranging study of Amitiza (lubiprostone) in patients with Chronic Idiopathic Constipation (CIC), conducted in Japan. The study demonstrated a statistically significant increase in mean change in spontaneous bowel movements (SBM) from baseline after one week on treatment (p less than 0.0001), the study's primary endpoint, for patients taking Amitiza 24 micrograms twice daily versus placebo.
Amitiza 24 mcg also demonstrated statistically significant improvement versus placebo for several secondary endpoints, including change in SBM after week 2, mean weekly SBM, percentage of patients having first SBM within 24 and 48 hours, degree of straining and stool consistency, abdominal bloating, abdominal discomfort, global assessment of severity of constipation, global assessment of treatment efficacy as well as a quality of life evaluation of treatment satisfaction.
A lower dose level of Amitiza, 16 mcg twice daily, also demonstrated statistically significant improvements over placebo in the primary endpoint and some of the secondary endpoints.
The randomized, parallel group, double-blind, placebo-controlled, multi-center phase 2b dose-ranging study compared the dose response of oral Amitiza with that of placebo in Japanese patients diagnosed with Chronic Idiopathic Constipation. The study evaluated 170 patients who were randomized to one of three twice-daily doses of Amitiza (8, 16 or 24 mcg) or placebo.
In general, Amitiza was well-tolerated. The most commonly reported adverse events (reported in greater than 5% of patients) included diarrhea, nausea, and stomach discomfort, and are consistent with previously reported Amitiza data.
"These results provide further validation of the safety and efficacy of Amitiza," said Ryuji Ueno, Sucampo Pharmaceuticals' chairman and chief executive officer. "While Amitiza has created a unique position in the US marketplace with approvals for both CIC in adults and Irritable Bowel Syndrome with Constipation (IBS-C) in adult women, international approvals are an important component in Sucampo's long-term growth strategy. The success of this trial allows Sucampo to plan for pivotal phase-3 studies for the Japanese market as well as a marketing partner."
"Based on these results, we plan to commence phase-3 clinical trials in Japan by mid-2009, moving Sucampo closer to our milestone of filing for marketing authorization for Amitiza in Japan for CIC," stated Gayle Dolecek, Sucampo Pharmaceutical's senior vice president of Research and Development, "We look forward to presenting the full results from this trial at an upcoming scientific meeting."
An end of phase-2 meeting with Japanese regulatory authorities has been scheduled to discuss the results of the phase-2 study and the proposed phase-3 programme.
Amitiza increases fluid secretion into the intestinal tract by activating specific chloride channels in cells lining the small intestine. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. In addition, Amitiza improves symptoms associated with chronic idiopathic constipation, including straining, hard stools, bloating and abdominal pain or discomfort.
Sucampo Pharmaceuticals, Inc, a biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones.
Amitiza (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women greater than or equal to 18 years of age and older.