Axcan enrolls over 1000 patients for dyspepsia study

The company has also enrolled more than 300 patients who will receive active medication for six months in accordance with the International Conference on Harmonisation guidelines. Recruitment activities are set to continue for a few weeks and Axcan expects to complete its phase III program in the fourth quarter of 2005.

Work has begun on preparing a new drug application for Itax which the company anticipates submitting to the FDA during the first half of 2006. Other regulatory filings in Canada and selected Western European countries will follow in the second quarter of 2006. Axcan expects to be able to launch the drug in 2007.

Itax is a patented oral gastroprokinetic drug containing itopride hydrochloride, which increases upper gastrointestinal motility and possesses antiemetic properties. In addition to functional dyspepsia Axcan plans to investigate the use of Itax for the treatment of diabetic gastroparesis and gastropathy.

Functional dyspepsia is a disorder of the upper gastrointestinal system, which, according to Axcan, affects up to 25% of the US population annually and accounts for up to 5% of all visits to primary care physicians in the US. Currently there are no known approved drugs for this indication in the US.