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Ironwood Pharmaceuticals Announces That The American Journal of Gastroenterology Publishes Full Results from Positive LINZESS® (linaclotide) Phase IIIb Trial in Adults with Irritable Bowel Syndrome with Constipation (IBS-C)
– Results demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adults with IBS-C – – LINZESS U.S.
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Results demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adults with IBS-C –\n\n– LINZESS U.S. prescribing information updated in September 2020 to reflect Phase IIIb data –\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that The American Journal of Gastroenterology – the official journal of The American College of Gastroenterology – published full results from the company’s Phase IIIb clinical trial evaluating LINZESS® (linaclotide) 290 mcg on multiple abdominal symptoms in adult patients with irritable bowel syndrome with constipation (IBS-C). The results, which can be viewed here, demonstrated that linaclotide 290 mcg administered orally once daily to adult IBS-C patients was associated with a statistically significant and clinically meaningful improvement in overall change in abdominal score compared to placebo. Ironwood reported topline results from this trial in June 2019.\n\nThe abdominal score, which comprises symptoms of bloating, pain and discomfort, reflects symptoms that have been identified by IBS-C patients as bothersome and important to treat.1 The trial was the first Phase III study to evaluate IBS-C treatment efficacy using the Diary for IBS Symptoms-Constipation (DIBSS-C), a patient-reported outcome instrument that assesses the three abdominal symptoms constituting the abdominal score, in addition to other symptoms of IBS-C.2,3\n\nFollowing U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) based on data from this trial, the LINZESS U.S. prescribing information was updated in September 2020 to reflect the impact of LINZESS on overall abdominal symptoms in adult IBS-C patients.\n\n“During patients’ conversations with their doctors, there is often an unfortunate but avoidable communication gap in which patients only describe their ‘constipation’ without discussing specific symptoms such as abdominal bloating, pain and/or discomfort,” said Lin Chang, M.D., vice chief at the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles. “Results from this trial may help physicians and patients have a more comprehensive discussion about these bothersome symptoms and ways to manage them.”\n\nRes...