Bazedoxifene and bazedoxifene combined with conjugated estrogens for the management of postmenopausal osteoporosis

Abstract

Bazedoxifene acetate (WAY-140424; TSE-424) is an investigational non-steroidal indole-based selective estrogen receptor modulator (SERM) – also classified as an estrogen agonist/antagonist – that is being developed as a daily oral drug for the prevention and treatment of postmenopausal osteoporosis (PMO). Clinical studies have shown favorable effects on the skeleton, with prevention of bone loss in postmenopausal women without osteoporosis and reduction in vertebral fracture risk in women with PMO, without stimulation of endometrium or breast. Bazedoxifene combined with conjugated estrogens is an investigational tissue-selective estrogen complex, the first in a new class of therapeutic agents that pairs a selective estrogen receptor modulator with estrogens. Clinical trials with bazedoxifene/conjugated estrogens in postmenopausal women have shown skeletal benefit with improvement in menopausal vasomotor symptoms and little or no stimulation of endometrial or breast tissue. Bazedoxifene/conjugated estrogens is a potential agent for the prevention of PMO and control of menopausal symptoms.

Keywords::

• bazedoxifene
• estrogen
• osteoporosis
• selective estrogen receptor modulators
• SERM
• tissue-selective estrogen complexes
• TSEC

Disclosure

EM Lewiecki has received financial support or owned personal investments in the following categories during the past year: i) as grant or research support: Merck, Eli Lilly, Novartis, sanofi-aventis, Amgen, Pfizer, Wyeth, Roche, GlaxoSmithKline and Procter & Gamble; ii) as a consultant, advisory board member, on the Speaker's bureau or at sponsored speaking events: Merck, Eli Lilly, Novartis, Procter & Gamble, sanofi-aventis, Roche, GlaxoSmithKline, Wyeth, Servier, Amgen and Upsher-Smith.