Axcan passes enrollment target for phase 3 trial of ITAX for functional dyspepsia

New York, Dec. 15 - Axcan Pharma Inc. said it has passed the goal of 500 patients for its North American phase 3 trial of ITAX (itopride) for functional dyspepsia.

Axcan said the clinical sites participating in the study will continue to add patients until the end of the month. As announced on Nov. 10, the international study has already reached its target.

The two pivotal phase 3 trials - the research in North America and internationally - are intended to assess the safety and efficacy of itopride in the treatment of functional dyspepsia, a gastrointestinal disorder.

Axcan expects results from the international study in the first half of next year with the North American data following shortly after. It plans to file a New Drug Application with the Food and Drug Administration in summer 2006.

No products are currently approved in North America to treat functional dyspepsia, Axcan said. Itopride acts as a dopamine antagonist on D2-receptors, increasing the secretion of acetylcholine, and also prevents hydrolysis of the released acetylcholine by the acetylcholinesterase enzyme in the smooth muscles. Acetylcholine is involved in the motor activity of the gastrointestinal tract and has been shown to have anti-emetic properties.

Axcan is a Mont-Saint-Hilaire, Quebec, pharmaceutical company specializing in gastroenterology.

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