Emerging drugs for functional dyspepsia.

INTRODUCTION: Functional dyspepsia (FD) is a highly prevalent condition with a major impact on quality of life and high socio-economic and healthcare costs. To date, no treatment of established efficacy in FD is available.

AREAS COVERED: This review of the literature summarizes recent progress in drug development for FD. Gastroprokinetics are considered therapeutically relevant in FD, although it has been difficult to prove symptomatic benefit. Recently studied drugs include 5-HT(4) receptor agonists (tegaserod), motilin receptor agonists (GSK962040 and others) and ghrelin receptor agonists (TZP-101, TZP-102). Fundic relaxant drugs are a novel approach to FD therapy. Recently studied drugs include 5-HT(1A) receptor agonists (buspirone, tandospirone, R137696) and acotiamide (or Z-338 or YM443), a first-in-class muscarinic M(1)/M(2) receptor antagonist and cholinesterase inhibitor. Extensive Phase II studies support the potential efficacy of acotiamide, especially for postprandial distress syndrome. In refractory cases, psychotropics are considered and recently studied agents include venlafaxine, which in a large multi-center study did not confirm efficacy, and a combination preparation of flupenthixol/melitracen, which showed potential efficacy in a small study.

EXPERT OPINION: While many new prokinetic drugs are in the early stages of evaluation, acotiamide emerges as the drug with a promising efficacy profile. Convincing evidence for the efficacy of psychotropics is lacking.