Linaclotide: a novel compound for the treatment of irritable bowel syndrome with constipation.

INTRODUCTION

Irritable Bowel Syndrome with constipation (IBS-C) is associated with abdominal pain and infrequent spontaneous bowel movements. Patients with Chronic Idiopathic Constipation do not have abdominal pain as a predominant symptom. Linaclotide represents a new class of medication approved in the USA for both of these common conditions. Linaclotide is approved for IBS-C only in the EU. The only other medication approved at this time for IBS-C is lubiprostone.

AREAS COVERED: This review will cover the mechanism of action of linaclotide, and review the pivotal pre-clinical and clinical trials leading to its approval in 2012. The indications, common side effects, and black box warnings listed for linaclotide are reviewed.

EXPERT OPINION: Linaclotide is superior to placebo for the treatment of both IBS-C and Chronic Idiopathic Constipation. The drug has minimal systemic bioavailability and a favorable safety profile. For IBS-C, it is appropriate as a first-line prescription treatment. For Chronic Idiopathic Constipation, osmotic or stimulant laxatives should be tried prior to using linaclotide due to their considerable lower cost.