Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation

19 July 2013

The European Medicines Agency has released a Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1 for a six-month public consultation.

Comments should be made using the submission form and sent no later than 15 January 2014 to [e-mail].

The proposed guideline will replace the existing Points to consider on the evaluation of medicinal products for the treatment of Irritable Bowel Syndrome. The main changes cover:

• the criteria to be used for patient selection in clinical trials (from Rome II to Rome III criteria) and the introduction of more flexibility with regard to disease classification;
• new recommendations on primary endpoints to be used in confirmatory clinical trials;
• dedicated chapters on subgroups of patients (male / female, children and the elderly) and on patients' geographical origin.