Data from the clinical trials will then be used as part of Merck’s FDA application for Arcoxia. The FDA issued Arcoxia with an “approvable” in October last year, but stated that additional safety and efficacy data would be needed before final approval could be offered.
Merck is currently conducting two clinical trials as part of the company’s efforts to supply this additional data.
The future of Arcoxia had become particularly uncertain following the market withdrawal of Vioxx late last year after it had been found to increase the risk of heart attack and stroke. Merck now expects to submit data from the two ongoing phase III trials in 2006.