24 June 2019 - - US-based pharmaceutical company Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Irish pharmaceutical company Allergan plc (NYSE: AGN) have received positive topline data from a Phase IIIb clinical trial evaluating Linzess (linaclotide) 290 mcg on multiple abdominal symptoms in adult patients with IBS-C, the companies said.
The trial met its primary multi-component endpoint and demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients compared to placebo.
The trial also met both secondary endpoints.
This trial was designed to highlight the impact of Linzess on the overall abdominal symptoms of bloating, pain and discomfort, which are part of patients' reported real-world experience, thereby enabling better communication about these symptoms.
Linzess is marketed by Ironwood and Allergan in the United States and is indicated for the treatment of adults with IBS-C or chronic idiopathic constipation.
Research has shown that approximately 95% of adults with IBS-C experience bothersome abdominal bloating, pain, and/or discomfort, with the majority experiencing these symptoms once a week or more. There are an estimated 13 m adults in the US with IBS-C.
Topline data from a randomized, double-blind, placebo-controlled Phase IIIb trial showed that linaclotide 290 mcg administered orally once daily demonstrated a statistically significant and clinically meaningful improvement in overall abdominal symptoms compared to placebo across the primary and both secondary endpoints.
In the multi-component primary endpoint, linaclotide-treated patients showed a 29.7% mean decrease from baseline in their weekly abdominal score (bloating, pain and discomfort) through the 12-week treatment period, compared to 18.3% for the placebo-treated patients (p