Wyeth reports strong Ph II data on TSECs

US drug major Wyeth presented strong Phase II clinical data on the use of a bazedoxifene/conjugated estrogens complex in postmenopausal women, which it believes could be the first in the new therapeutic class of tissue-selective estrogen complexes.

According to Phase II trial findings reported at the annual meeting of the American Society for Reproductive Medicine, held in New Orleans, several dose combinations of a TSEC containing bazedoxifene/conjugated estrogens were associated with a decrease in hot flashes compared to placebo, amenorrhea rates similar to placebo and no increase in endometrial thickness compared to placebo.

New Jersey-based Wyeth noted that pairing bazedoxifene with conjugated estrogens resulted in a dose-related decrease in endometrial thickness and was similar to placebo at some dose combinations. Treatment with the conjugated agent was associated with amenorrhea rates greater than 84% in all participants and was similar to placebo at the doses studied. In addition, there was a significant reduction of hot flashes in all treatment groups compared to placebo, the firm added.