As expected, the FDA has told Merck that it will need to provide more safety data on Arcoxia before it can be approved as a successor to Vioxx, its Cox-2 inhibitor pulled after being linked to scores of heart attacks and strokes. Merck said this morning that it will continue with two late-stage trials of Arcoxia, including one two-year trial. Merck says that it will provide new data from the Phase III trials in 2006.
- read this article from the AP for more