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Axcan Exceeds Patient Randomization Target Necessary for Completion of North American ITAX (Itopride) Phase III Trial - Company is on Track for NDA Filing in the Summer of 2006
Axcan Exceeds Patient Randomization Target Necessary for Completion of North American ITAX (Itopride) Phase III Trial - Company is on Track for NDA Filing in the Summer of 2006.
About this update from Trailbreaker Resources Ltd
[{"type":"text","content":"\n\n\n\n\nTSX SYMBOL (Toronto Stock Exchange): AXP\nNASDAQ SYMBOL (NASDAQ National Market): AXCA\n\nMONT-SAINT-HILAIRE, QC, Dec. 15 /CNW Telbec/ - Axcan Pharma Inc. (NASDAQ:\nAXCA - TSX: AXP) announced today that clinical sites participating in the\nNorth American ITAX (itopride) Phase III trial have exceeded the goal of\nrandomizing 500 patients. Additional patients are still in the screening\nprocess, and Axcan intends to continue randomization until the end of December\n2005, consistent with previously announced study timelines. As disclosed on\nNovember 10, 2005, all patients required for completion of the international\nstudy have already been randomized.\nThe goal of this clinical development program, consisting of two pivotal\nPhase III trials, a North American and an international clinical study, is to\nassess the safety and efficacy of Itopride in the treatment of Functional\nDyspepsia, a gastrointestinal disorder.\n\"This is a significant accomplishment for Axcan, and we are extremely\npleased to have achieved this important milestone in the development of\nItopride. We have been successful in implementing an action plan designed to\nmeet our randomization goal, which involved an increase of 50% in the number\nof sites in the North American trial. We continue to be committed to filing a\nNew Drug Application with the U.S. Food and Drug Administration in the summer\nof 2006,\" said Frank Verwiel, M.D., President and Chief Executive Officer of\nAxcan. \"This achievement was further made possible by the dedication and hard\nwork of the clinical investigators, the study site personnel and our own\nresearch and development team,\" concluded Dr. Verwiel.\nAxcan expects to release the overall outcome of the international\nPhase III clinical trial during the first half of calendar 2006, followed\nshortly afterwards by that of the North American Phase III trial. Detailed\nresults of the studies will most likely be subsequently presented at a major\ngastroenterology scientific conference.\n\nAbout Functional Dyspepsia\n\nFunctional Dyspepsia, a disorder of the upper gastrointestinal tract,\naffects up to 25 percent of the North American population annually and\naccounts for up to 5 percent of all visits to primary care physicians.\nDyspepsia can be defined as pain or discomfort centered in the upper abdomen,\ncharacterized by ab...