In both studies, AMITIZA demonstrated increases in the percentage of patients who experienced SBMs within the first 24 hours after administration when compared to placebo (56.7% vs. 36.9% in Study 1 and 62.9% vs. 31.9% in Study 2, respectively). Similarly, the time to first SBM was shorter for patients receiving AMITIZA than for those receiving placebo.

Signs and symptoms related to constipation, including abdominal bloating, abdominal discomfort, stool consistency, and straining, as well as constipation severity ratings, were also improved with AMITIZA versus placebo. The results were consistent in subpopulation analyses for gender, race, and elderly patients ( ≥ 65 years of age).

Following 4 weeks of treatment with AMITIZA 24 mcg twice daily, withdrawal of AMITIZA did not result in a rebound effect.

Long-term Clinical Studies

Three open-labeled, long-term clinical safety and efficacy studies were conducted in patients with chronic idiopathic constipation receiving AMITIZA 24 mcg twice daily. These studies comprised 871 patients (mean age 51.0 [range 19–86] years; 86.1% female; 86.9% Caucasian, 7.3% African American, 4.5% Hispanic, 0.7% Asian; 18.4% ≥ 65 years of age) who were treated for 6–12 months (24–48 weeks). Patients provided regular assessments of abdominal bloating, abdominal discomfort, and constipation severity. These studies demonstrated that AMITIZA decreased abdominal bloating, abdominal discomfort, and constipation severity over the 6–12-month treatment periods.

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