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Salix Pharmaceuticals Ltd Announces Results For Budesonide Foam In Treatment Of Active Mild To Moderate Ulcerative Proctitis Or Ulcerative Proctosigmoiditis In Two Pivotal Phase 3 Studies


Wednesday, 22 May 2013 07:00am EDT 

Salix Pharmaceuticals Ltd announced the completion and outcome of two pivotal Phase 3 studies to evaluate the efficacy and safety of budesonide foam in the treatment of active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). In each of the two pivotal Phase 3 studies, a statistically proportion of subjects treated with budesonide foam achieved clinical remission compared to subjects treated with placebo foam. The two randomized, double-blind, placebo-controlled, multicenter studies in subjects who present with a diagnosis of active mild to moderate UP or UPS were designed to establish the efficacy profile of rectally administered budesonide foam administered as 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. During the study, subjects were allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8 grams per 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. 

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25 Jul 2014