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Ironwood Pharmaceuticals Reports Positive Topline Data from Phase III Trial of LINZESS® (linaclotide) in Pediatric Patients Aged 6-17 with Functional Constipation
– Study met primary and secondary endpoints – – Results add to body of data supporting the safety of linaclotide for this patient population – – There are
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Study met primary and secondary endpoints –\n\n– Results add to body of data supporting the safety of linaclotide for this patient population –\n\n– There are currently no FDA approved prescription pediatric therapies for Functional Constipation (FC); FC affects an estimated 4 to 6 million children ages 6 to 17 in the United States1 –\n\n– Ironwood and its partner, AbbVie, to evaluate a potential supplemental New Drug Application (sNDA) submission –\n\n BOSTON, Mass.--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), today announced positive topline data from a Phase III clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC). The trial met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved frequency of spontaneous bowl movements (SBM) and stool consistency. Linaclotide was generally well-tolerated, and the safety profile is consistent with previously reported studies with linaclotide in FC and irritable bowel syndrome (IBS) in pediatric patients.\n\n“Functional constipation is one of the most common gastrointestinal complaints in pediatric patients, one that significantly impacts young patients’ lives. Despite its high prevalence, FC remains challenging to treat because there are no FDA approved prescription treatments for children,” said Jeffrey S. Hyams, MD, Head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine. “These strong data further our understanding of the safety profile of linaclotide in pediatric patients aged 6-17 with FC and demonstrate evidence of its potential to provide therapeutic benefit to these patients suffering from FC.”\n\nIn this study, a total of 330 patients were randomized in a 1:1 ratio between linaclotide or placebo. Topline data indicate that linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate (SBMs/week), the primary endpoint. Linaclotide-treated patients demonstrated a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo (1.050) (p","length":3047,"tagName":"div"}]