CHMP considering new IBS trial guidelines

EMA's CHMP is considering changes to 2003 guidance on the design of clinical trials for irritable bowel syndrome (IBS), according to a concept paper published last week. The committee wants to incorporate new recommendations from FDA's recently issued IBS guidance, which recommends a co-primary endpoint of pain intensity and either stool frequency for IBS with constipation trials or stool consistency for IBS with diarrhea trials. EMA's 2003 guidelines recommend endpoints of global assessment of symptoms and assessment of symptoms of abdominal discomfort/pain.

CHMP also wants to allow the acceptance of foreign data to support approval of an IBS drug in the EU. The committee said most IBS trials have been conducted in North America. Comments on the proposals are due Aug. 31, with draft guidelines expected in 4Q12. A final document is expected by year-end 2013. FDA published final IBS guidance in May (see BioCentury Extra, May 30). ...