Development of therapies to treat irritable bowel syndrome (IBS) depends upon critical communication from the patient about symptoms such as abdominal pain and bloating that cannot be measured any other way. There is an abundance of literature on available outcome measures in IBS, however, the development and validation methods used to define these measures may not meet FDA’s regulatory expectations. Hence, the IBS Working Group is developing new PRO measures for each of the three main IBS subtypes: IBS – diarrhea predominant, IBS – constipation predominant, and IBS – mixed. These measures will be used to assess primary endpoints in treatment trials for IBS.
Working Group Sponsors
Ironwood Pharmaceuticals, Inc.