Axcan Pharma Incs’ clinical sites participating in the North American Itax (itopride) phase III trial have exceeded the goal of randomising 500 patients. Additional patients are still in the screening process, and Axcan intends to continue randomisation until the end of December 2005, consistent with previously announced study timelines. All patients required for completion of the international study have already been randomised.

According to the company release, the goal of this clinical development programme, consisting of two pivotal phase III trials, a North American and an international clinical study, is to assess the safety and efficacy of itopride in the treatment of functional dyspepsia, a gastrointestinal disorder.

"This is a significant accomplishment for Axcan, and we are extremely pleased to have achieved this important milestone in the development of itopride. We have been successful in implementing an action plan designed to meet our randomisation goal, which involved an increase of 50% in the number of sites in the North American trial. We continue to be committed to filing a new drug application with the US Food and Drug Administration in the summer of 2006," said Frank Verwiel, president and chief executive officer of Axcan.

Axcan expects to release the overall outcome of the international phase III clinical trial during the first half of calendar 2006, followed shortly afterwards by that of the North American phase III trial. Detailed results of the studies will most likely be subsequently presented at a major gastroenterology scientific conference.

Functional dyspepsia, a disorder of the upper gastrointestinal tract, affects up to 25 per cent of the North American population annually and accounts for up to 5 per cent of all visits to primary care physicians. Dyspepsia can be defined as pain or discomfort centred in the upper abdomen, characterised by abdominal fullness, early satiety, bloating, or nausea, without evidence of organic disease to explain the symptoms.

Itopride is a gastroprokinetic drug effective through a dual action mechanism of action.

Axcan is a specialty pharmaceutical company specialised in the field of gastroenterology.