Salix announced the completion and outcome of two Phase 3 studies evaluating the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). A statistically significant proportion of patients treated with budesonide foam achieved clinical remission compared to those treated with placebo foam. Budesonide is a potent, non-halogenated, synthetic glucocorticosteroid that has anti-inflammatory, anti-allergic, anti-exudative, and anti-edematous properties.
The two randomized, double-blind, placebo-controlled, multicenter studies evaluated the efficacy of rectally administered budesonide foam 2mg/25mL twice daily for two weeks followed by 2mg/25mL once daily for four weeks, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule in patients diagnosed with active mild to moderate UP or UPS. During the study, participants were allowed to maintain previously established oral 5-ASA treatment at doses of up to 4.8g/day. The primary end point was the proportion of subjects who achieved remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI), at the end of 6 weeks of treatment or withdrawal. In each of the two pivotal Phase 3 studies, a statistically significant proportion of subjects treated with budesonide foam achieved clinical remission compared to subjects treated with placebo foam.
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