Ironwood Pharmaceuticals Initiates Phase IIIb Study of Linaclotide in Adult Patients with Irritable Bowel Syndrome with Constipation (IBS-C

Ironwood Pharmaceuticals (NASDAQ:IRWD) has announced the initiation of a Phase IIIb clinical trial evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms in addition to pain such as bloating and discomfort, in adult patients with irritable bowel syndrome with constipation (IBS-C).

As quoted in the press release:

Linaclotide is a guanylate cyclase-C (GC-C) agonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC).

“There are an estimated 13 million adult IBS-C patients in the U.S., and more than two thirds of them report suffering from symptoms such as abdominal bloating and discomfort at least once per week. These symptoms are often a primary complaint and reason for patients seeking care,” said Christopher Wright, M.D., Ph.D., senior vice president, global development and chief development officer at Ironwood. “As IBS-C patients often describe their abdominal symptoms as bloating or discomfort, rather than pain, this can lead to under-treatment. If positive, we believe these data should further enable more effective communication between patients and physicians on both IBS-C and the role that linaclotide can play in treating the millions of appropriate patients suffering from IBS-C.”

The randomized, double-blind, placebo-controlled, parallel-group study aims to enroll approximately 600 adult IBS-C patients in the United States. Eligible patients will be randomized to placebo or linaclotide 290 mcg once daily for 12 weeks, followed by a four-week randomized withdrawal period.

Click here to read the full press release.