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Wyeth’s Bazedoxifene Reduces Vertebral Fractures in Postmenopausal Women
The trial of bazedoxifene 20 mg indicated a significant reduction in new vertebral fractures in postmenopausal women with osteoporosis, the company said in a press release.
The results were from a two-year extension of a three-year Phase 3 trial, which enrolled 7,492 generally healthy postmenopausal women aged 55 to 85 years with osteoporosis.
At five years, the study showed that the incidence of new vertebral fractures was significantly reduced in the bazedoxifene 20 mg group (4.5%) and in the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with placebo (6.8%).
These and other data were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Denver, Colorado.
“These new data are important in that they suggest the reduction in vertebral fracture risk with bazedoxifene seen at five years is comparable to that seen at three years,” says Stuart Silverman, Clinical Professor of Medicine at the University of California, Los Angeles and Cedars-Sinai Medical Center, and the study’s lead investigator.
But Wyeth has had trouble getting the drug approved in the U.S. In May, it received, for the third time, a letter from the FDA delaying an approval decision. The FDA wanted further analysis about the rate of stroke and other events related to blood clots, and also had some questions about data collection.
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