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 E-Mail TUCSON, Ariz., January 7, 2021 Critical Path Institute s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS® (linaclotide). The DIBSS-C was developed by the PRO Consortium s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS®. This is the first time a PRO Consortium measure has been used to support a label claim.

United statesRobynt carsonCecielt rookerConsortium diary for irritable bowel syndrome symptomsConsortium irritable bowel syndromeHuman servicesInternational foundation for gastrointestinal disordersUs department of healthDrug administrationOutcomes researchCritical path instituteClinical outcome assessment qualification programOutcome consortiumDrug administration centerCritical path institute patientPath institute