Axcan, FDA to determine effect of ITAX phase 2, phase 3 trial data on next phase 3 study

By Lisa Kerner

Charlotte, N.C., June 28 - Axcan Pharma Inc. said it will meet with the Food and Drug Administration to evaluate the impact of post-hoc analyses of the ITAX phase 2 and international phase 3 trial data on a planned North American pivotal phase 3 trial.

As a result, the database of the North American phase 3 study has been locked and data from the phase 2 study remain blinded.

The ITAX international phase 3 trial failed to meet its co-primary endpoints of response rate using the Leeds Dyspepsia Questionnaire and response rate based on the Patient's Global Assessment of Efficacy.

"Preliminary results noted in post-hoc analyses provide insights we would like to review and discuss with the FDA, as the phase 3 clinical study program for ITAX may provide a unique opportunity to improve our understanding of the effect of Itopride on functional dyspepsia," president and chief executive officer Frank Verwiel said in a company news release.

"Our current objective is to evaluate, in the context of the entire clinical development program and in consultation with the FDA, any potential impact these findings could have on the statistical analysis plan of the North American phase 3 trial before unblinding the data.

ITAX is a patented oral gastroprokinetic drug for the treatment of gastrointestinal symptoms caused by reduced gastrointestinal motility.

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

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