A post-hoc subgroup analysis of women at higher fracture risk showed that bazedoxifene 20mg reduced the incidence of non-vertebral fracture by 52% relative to placebo.
With regard to the safety and tolerability observed in this clinical trial, a non-statistically significant increase in the incidence of venous thromboembolic events was observed in all active treatment groups compared with the placebo group. No safety concerns related to the reproductive systems, including breast, were observed in the bazedoxifene treatment groups.
Wyeth received an approvable letter relating to its pending new drug application for bazedoxifene for the prevention of postmenopausal osteoporosis from the FDA on April 23, 2007. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis. The efficacy data for bazedoxifene presented at the meeting represents only a portion of the totality of safety and efficacy data that the company has submitted to the FDA.
In the trial, which enrolled 7,492 postmenopausal women between the ages of 55 and 85 with moderate to severe osteoporosis, bazedoxifene showed significant risk reduction, compared with placebo, for new vertebral fractures. Specifically, the three-year incidences of new vertebral fracture were 2.3%, 2.5%, 2.3% and 4.1% in the bazedoxifene 20mg, bazedoxifene 40mg, raloxifene 60mg and placebo groups, respectively.