EMA final guidelines for IBS trials

EMA published final guidelines for irritable bowel syndrome (IBS) revising the recommended co-primary endpoints for placebo-controlled trials. The guidance is in line with July 2013 draft guidance recommending co-primary endpoints of abdominal pain and either stool frequency for constipation-predominant IBS or stool consistency for diarrhea-predominant IBS.

The new EMA guidelines are consistent with FDA's final guidance on IBS trials published in 2012, which recommends the same co-primary endpoints. ...