Axcan terminates indigestion drug trial

The study did not demonstrate a statistically significant effect of Itopride in improving the symptoms of upper abdominal pain and fullness, and did not meet the analysis plans for the study set down by the company and the FDA. In addition, the trial did not demonstrate a statistically significant finding from results of a patient global assessment questionnaire that measured efficacy.

“Although we are disappointed by these results, we will continue to thoroughly analyze the data from this study,” said Frank Verwiel, president and CEO of Axcan.

“Based on current insights, we do not think that there is enough evidence of efficacy of Itopride, even when combining the results of both the International phase III study reported earlier this year and the phase II study conducted in Germany, to support a path for development of Itopride for Functional Dyspepsia. As a consequence, we have decided to suspend further development of Itopride in this indication.”

The company said the decision to end the study would probably result in a reduction in research and development expenses.