The FINANCIAL -- Pfizer will announce new one-year results from the Selective estrogens, Menopause, And Response to Therapy Phase 3 study of the safety and efficacy of the investigational tissue selective estrogen complex  bazedoxifene/conjugated estrogens at the 22nd annual meeting of the North American Menopause Society, September 21-24 in Washington, D.C. BZA/CE is being developed by Pfizer for the treatment of moderate-to-severe hot flashes, vulvar and vaginal atrophy and the prevention of osteoporosis in women following menopause.

SMART-5 was a one-year study that investigated over 1,800 postmenopausal women who had not had a hysterectomy. The study was designed to assess the safety and efficacy of two doses of BZA/CE treatment on the endometrial lining of the uterus and evaluate the efficacy of BZA/CE for the prevention of osteoporosis. All primary and secondary endpoints in SMART-5 were met. The most common adverse effects seen in women treated with BZA/CE in SMART-5 were back pain, inflammation of the nose and throat and headache.

These data provide new insights about BZA/CE. The blended tissue selective activity of the components of a TSEC – a selective estrogen receptor modulator paired with one or more estrogens - is believed to yield different clinical results than those provided by the components alone. BZA/CE was not shown to increase vaginal bleeding, breast density or breast pain when compared to placebo in SMART-5.

It is hypothesized that BZA/CE could provide a new treatment option for symptomatic postmenopausal women with a uterus.

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