Acotiamide (Z-338, YM443), a new drug for the treatment of 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. Acotiamide (Z-338 or YM443) is a new drug under development for the treatment of FD. AREAS COVERED: Acotiamide is a gastroprokinetic drug that enhances acetylcholine release in the enteric nervous system via muscarinic receptor antagonism and acetycholinesterase inhibition. In conscious rats and dogs, acotiamide enhanced gastric contractility and accelerated delayed gastric emptying. Although in healthy volunteers acotiamide did not affect gastric emptying, gastric emptying and gastric accommodation were enhanced in FD. Acotiamide was evaluated in FD in several clinical studies in different countries and these are supportive of a symptomatic benefit. The beneficial effect is most consistently found with the 100 mg dose (three times a day) and primarily involves the postprandial distress syndrome symptoms of postprandial fullness, early satiety and upper abdominal bloating. The mechanism underlying the symptomatic benefit with acotiamide is not fully established but may involve enhanced gastric accommodation and increased gastric emptying. EXPERT OPINION: Compared to placebo, no adverse events have been reported in the current short-term studies, while acotiamide seems efficacious for treating postprandial distress syndrome symptoms in FD patients.