For the treatment of IBS-C and CIC

^bIn Study 3 of IBS-C patients, a responder was defined as a patient who met both the abdominal pain intensity and stool frequency responder criteria in the same week for at least 6 of the 12 treatment weeks, which were defined as an abdominal pain intensity responder (a patient who experienced a decrease in the weekly average score of worst abdominal pain in the past 24 hours [measured daily] of ≥30% compared to weekly baseline average) and stool frequency responder (a patient who experienced an increase of at least 1 complete spontaneous bowel movement per week from baseline).^1,2

^cIn 12-week clinical studies, more Trulance-treated patients had improvements in stool frequency (as measured by increased CSBMs, 21–48% Trulance vs 10–35% placebo) and consistency of bowel movements (as measured by mean increase in BSFS score, 1.5 Trulance vs 0.8–0.9 placebo).^1,2,4,5

^dAbdominal pain and constipation were components of the primary endpoint. Mean change from baseline in abdominal symptoms, including bloating, were measured as a secondary endpoint over 12 weeks in Phase III registrational trials. In clinical studies, more Trulance-treated patients were IBS-C abdominal pain responders (33–41%) compared to placebo (23–32%). Greater improvements in mean bloating score were also seen with Trulance (0.5–1.5) as compared to placebo (0.4–1.1).^1,2,4,5