ArcoxiaTreatment for Osteoarthritis
Merck Provides Status Update on Ongoing Arcoxia Trials
WHITEHOUSE STATION, N.J., June 17, 2005 - As previously announced, on Oct. 29, 2004, Merck & Co., Inc. received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Arcoxia (etoricoxib). The FDA informed Merck in that letter that before approval of the NDA can be issued, additional safety and efficacy data for Arcoxia are required. These data will include data from ongoing clinical trials for Arcoxia, known as MEDAL and EDGE II. These trials are being monitored by a Data Safety Monitoring Board (DSMB) responsible for the ongoing safety of the trials. The DSMB met recently and recommended that the studies continue as planned. Merck remains blinded to the clinical data from these trials.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service.
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Posted: June 2005
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