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news.Axcan Pharma's drug candidate for the treatment of functional dyspepsia, Itopride, has failed to meet its primary endpoint in an international phase III trial. As such, the results from the trial have failed to confirm the efficacy of the drug that previous trials have demonstrated.
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Axcan said that it will decide on whether or not to continue developing the drug in its functional dyspepsia indication after it has further evaluated data from the phase III trials. The company will, however, continue the development of this compound in other areas, such as diabetic gastropathy.
“We are obviously surprised with the results of the Itopride International phase III trial, particularly in view of the positive results seen in the soon-to-be published phase II trial and in the preclinical data that provided strong mechanistic support for Itopride,” commented Dr Frank Verwiel, president and CEO of Axcan.