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ARTICLE | Clinical News

Menarini reports Phase II data for ibodutant

September 21, 2012 10:58 PM UTC

Menarini Group (Florence, Italy) reported top-line data showing that once-daily 10 mg ibodutant met both the EMA and FDA primary endpoints in the Phase II IRIS-2 trial to treat irritable bowel syndrome with diarrhea (IBS-D). Specifically, a significantly greater proportion of patients receiving ibodutant achieved combined satisfactory relief of overall IBS symptoms and abdominal pain in six of eight weeks of treatment vs. placebo (40% vs. 27%, p=0.032) -- the EMA endpoint. Ibodutant also led to a significantly greater proportion of patients achieving a 30% or greater reduction in weekly average worst abdominal pain and a 50% or greater reduction in the number of days with one or more liquid or watery stool in four of eight weeks of treatment (49% vs. 37%, p=0.048) -- the FDA endpoint. ...