Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated...(e Efficacy andSafety of Bazedoxifene/Con...),Health

Date:10/5/2007

e Efficacy and Safety of Bazedoxifene/Conjugated Estrogens for Treatment of Menopausal Vasomotor Symptoms," which evaluated 332 symptomatic postmenopausal women who, at baseline, experienced seven or more moderate to severe hot flashes per day or 50 or more hot flashes per week were presented. The study showed that, when compared with placebo, bazedoxifene/conjugated estrogens significantly reduced the number and severity of hot flashes. Furthermore, the incidences of breast pain and bleeding were less than 5 percent and did not differ from placebo. The most commonly reported adverse events were headache and joint pain.

Data from another Phase 3 study titled "Effects of the TSEC Bazedoxifene and Conjugated Estrogens on Vulvar/Vaginal Atrophy and Sexual Function in Postmenopausal Women," which evaluated 601 postmenopausal women with moderate to severe vulvar and vaginal atrophy, also were presented. These data showed that bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy, including dryness. In addition, bazedoxifene/conjugated estrogens improved vaginal lubrication, sexual function and menopause-related quality of life, when compared with placebo. The incidences of breast pain and bleeding were less than 5 percent and did not differ from placebo. There were no differences among groups in the incidences of adverse events and discontinuation rates.

"Bazedoxifene/conjugated estrogens, if approved, will be a new and different therapeutic option that has the potential to change the way physicians and their patients treat menopausal symptoms and prevent postmenopausal osteoporosis," says Dr. Constantine.

The efficacy and safety data for bazedoxifene/conjugated estrogens presented at this meeting represents only a portion of the totality of data available at this time.

About Menopause

According to the U.S. Census Bureau, in 2006, there were approximately 20 million women of menopausal age (45-54 years) in the Uni
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