Linaclotide Recently Received FDA Approval for IBS with Constipation

In two trials, about 15% more patients with irritable bowel syndrome responded to linaclotide than to placebo.

Linaclotide (Linzess) recently was FDA approved for two indications, chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). The drug is minimally absorbed and works by increasing intestinal luminal fluid secretion and intestinal transit. Results of chronic constipation trials were published in 2011 (JW Gen Med Sep 6 2011). Now, these researchers have published results of two trials in which 1600 patients (90% women) with IBS-C were randomized to receive daily linaclotide (290 µg) or placebo. Enrollment criteria included a score of at least 3 (on a 10-point scale) for daily abdominal pain and an average of <3 complete spontaneous bowel movements weekly.

A combined primary endpoint was ≥30% improvement in the a…

Reviewing Author

Allan S. Brett, MD

Disclosures

Nothing to disclose

Allan S. Brett, MD

Disclosures

Nothing to disclose