MERCK CLEARED TO CONTINUE ARCOXIA SAFETY TRIALS
Merck's two clinical studies examining the safety of its yet-to-be-approved Cox-2 inhibitor Arcoxia are allowed to continue following a recent meeting of a Data Safety Monitoring Board (DSMB) responsible for overseeing the trials.
Merck is currently conducting two long-term safety trials - the Etoricoxib Diclofenac Gastrointestinal Evaluation 2 (EDGE-2) and Multi-national Etoricoxib Diclofenac Arthritis Long-term trials (MEDAL) - to support resubmission of its new drug application for Arcoxia (etoricoxib). The FDA deemed Arcoxia "approvable" in October 2004, but said Merck would have to provide additional safety data before the drug could receive final approval.
The DSMB overseeing the Arcoxia trials met recently and recommended the studies continue as planned, Merck said recently. Merck expects the trials to be completed in 2006.
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