Amitiza is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for IBS-C in women aged 18 years and old.
In the two pivotal Phase 3 placebo-controlled 12-week studies, patients were randomised in a 2:1 ratio to receive lubiprostone 8mcg, or placebo, twice daily (BID) to investigate improvements in subsets of patients with moderate to very severe IBS-C.
Patients treated with Lubiprostone showed greater-than or equal to 30% improvement form baseline in mean abdominal pain scores, greater-than or equal to one SBM per week improvement over baseline and greater-than or equal to three SBMs per week compared to placebo for six of 12 weeks and for nine of 12 weeks.
Lubiprostone also reported significant reduction in abdominal pain overall on a weekly basis over 12 weeks of treatment, with 35.1% of patients demonstrating a 30% or greater reduction in abdominal pain as compared to baseline.
Sucampo Pharmaceuticals chair CEO and chief scientific officer Ryuji Ueno said the data from the analysis adds to the understanding of Amitiza’s role in the treatment of moderate to severe IBS-C.