COLLEGEVILLE, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announces findings from a placebo-controlled Phase 3 study of bazedoxifene 20 mg extended to five years, which indicated a significant reduction versus placebo in new vertebral fractures in postmenopausal women with osteoporosis. These and other data were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Denver, Colo. Bazedoxifene, a selective estrogen receptor modulator (SERM), is under clinical investigation for the prevention and treatment of postmenopausal osteoporosis.
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Additional New Bazedoxifene Data Presented at ASBMR
Data were also presented from a post-hoc analysis performed using the Fracture Risk Assessment Tool (FRAX(R)), which was developed by the World Health Organization to calculate a woman’s 10-year risk of experiencing an osteoporotic fracture. This post-hoc analysis indicated that the higher a woman’s risk of a fracture, the greater the reduction in non-vertebral fractures when receiving bazedoxifene therapy based on her FRAX score.
Bazedoxifene five-year safety and tolerability data in postmenopausal women with osteoporosis were also presented. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar to that seen in the placebo group. The incidence of cardiac or cerebrovascular events, including myocardial infarction and stroke, in the bazedoxifene treatment groups was similar to that seen in the placebo group. Subjects treated with bazedoxifene had a higher incidence of deep venous thrombosis, hot flushes and leg cramps compared with placebo-treated subjects. The effect of bazedoxifene on the breast and endometrium was comparable to placebo.
Data from an analysis performed using a Marcov cohort model and published U.S. cost and epidemiological data evaluated the potential cost-effectiveness and intervention thresholds of bazedoxifene treatment (20 mg and 40 mg doses combined) compared to placebo. Cost-effective scenarios were projected for women with strong risk factors and with a T-score above the threshold for osteoporosis. When effect was modeled for non-vertebral fractures, the data suggested that potential cost effectiveness improved further in women from the age of 60 years with prior fracture and at the threshold of osteoporosis (T-score=-2.5 SD).
Wyeth is pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States and other countries worldwide. In April 2009, the European Commission granted marketing authorization for CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Wyeth intends to introduce CONBRIZA in certain European markets following receipt of necessary reimbursement authorizations in those markets.
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About Wyeth Pharmaceuticals
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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