Asimadoline and its potential for the treatment of diarrhea-predominant irritable bowel syndrome: a review

Abstract

Irritable bowel syndrome (IBS) is a multifactorial condition with principal symptoms of pain and altered bowel function. The kappa-opioid agonist asimadoline is being evaluated in Phase III as a potential treatment for IBS. Asimadoline, to date, has shown a good safety profile and the target Phase III population – diarrhea-predominant IBS patients with at least moderate pain – was iteratively determined in a prospective manner from a Phase II dose-ranging study. The clinical data in support of this population are reviewed in this article. Furthermore, the scientific rationale for the use of asimadoline in the treatment of IBS is reviewed. Considering the high patient and societal burdens of IBS, new treatments for IBS represent therapeutic advances.

Keywords:

• irritable bowel syndrome
• kappa-opioid agonist
• asimadoline
• visceral pain
• visceral hypersensitivity

Disclosure

During the past year, A Mangel has participated in projects for the following sponsors: C-Path Institute, Tucson, AZ; Tioga Pharmaceuticals, San Diego, CA; Theravance, South San Francisco, CA; Novartis International AG, Basel, Switzerland; GlaxoSmithKline (GSK), London, UK; Pfizer, NY; and Boehringer, Binger Str, Ingelheim, Germany. A Mangel is an employee of RTI Health Solutions, Research Triangle Park, NC. RTI Health Solutions met the costs for preparation of this manuscript. G Hicks is an employee of Tioga Pharmaceuticals.