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November 20, 2012
16:12 EDTXOMAXOMA says Phase 3 PATH trial meets primary endpoint
XOMA announced the 837-patient Phase 3 PATH trial of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC, containing a patent-protected proprietary form of perindopril, was licensed by XOMA as part of a U.S. commercial and development rights agreement signed with Servier for their perindopril franchise. Servier markets the fixed-dose combination product, COVERAM, in 91 countries outside the U.S. The FDC appeared to be well tolerated in the trial, and there were no unexpected serious adverse events reported. The most common adverse events included mild to moderate edema, cough and headache, which are known side effects of the individual components of the FDC, the company said.
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