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Home Industry News Wyeth announces analysis of bazedoxifene

Wyeth announces analysis of bazedoxifene

30th September 2008

Wyeth has announced a retrospective analysis of phase III data suggesting women administered with bazedoxifine/conjugated oestrogens (BZA/CE) have an incidence of abnormal mammograms and breast tenderness comparable to those receiving placebo.

The results of this analysis were presented at the annual meeting of the North American Menopause Society.

In total, 3,397 postmenopausal women were involved in the study, with mammograms taken at baseline and years one and two as part of the safety evaluation, while breast tenderness was recorded by patients in daily diaries.

The company said it is assessing BZA/CE as a treatment for moderate-to-severe menopausal vasomotor symptoms, such as night sweats and hot flashes.

Wyeth also said the investigational compound is being evaluated as a therapy to prevent postmenopausal osteoporosis.

In another study of BZA alone, the compound did not appear to increase mammographic breast density in postmenopausal women with osteoporosis when compared to active comparator raloxifene or placebo over a two-year period.

Mammograms were studied in a subset of 726 postmenopausal women from a primary phase III fracture study of BZA, raloxifene and placebo.

“BZA is an investigational selective estrogen receptor modulator under development for the treatment and prevention of postmenopausal osteoporosis,” Wyeth said.

In May 2008, Wyeth Pharmaceuticals said it had been issued with an approval letter for bazedoxifine from the US Food and Drug Administration.

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