Axcan says itopride fails to meet goals in second phase 3 trial for functional dyspepsia

New York, Sept. 20 - Axcan Pharma Inc. said ITAX (itopride) failed to meet the co-primary endpoints in the North American phase 3 trial of the drug for treatment of functional dyspepsia.

The Mont-Saint-Hilaire, Quebec, specialty pharmaceutical company said it was abandoning development of itopride for functional dyspepsia based on the latest results and those from the previously announced international phase 3 study.

In the latest research, itopride did not demonstrate a statistically significant effect in improving the symptoms of upper abdominal pain and fullness either under the predefined initial statistical analysis plans for the study or the revised plan subsequently agreed with the Food and Drug Administration.

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