– Results demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adults with IBS-C –
– LINZESS U.S. prescribing information updated in September 2020 to reflect Phase IIIb data –
BOSTON--(BUSINESS WIRE)-- Ironwood 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.
The 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
Following 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.
“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.”
Research has shown that approximately 95% of surveyed adults with IBS-C reported experiencing bothersome abdominal bloating, pain and/or discomfort, with the majority reporting that they experience these symptoms once a week or more.4,5 There are an estimated 11.5 million adults in the U.S. with IBS-C.2
“The Phase IIIb data expand and strengthen the clinical profile of LINZESS, underscoring its value as a treatment option for adult patients with IBS-C,” said Mike Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of drug development at Ironwood. “We continue to educate physicians and patients on these data and the clinical benefits of LINZESS on multiple abdominal symptoms associated with IBS-C, with the goal of enabling improved communication between them and thereby meeting patients’ needs more effectively.”
For the multi-component primary endpoint of overall change from baseline in the abdominal score (the average of bloating, discomfort and pain symptoms at their worst), linaclotide demonstrated a significant improvement compared to placebo over the 12 weeks of the trial: -1.9 (29.7% decrease from baseline) with linaclotide vs. -1.2 (18.3% decrease) with placebo (p