WASHINGTON--(BUSINESS WIRE)--Pfizer Inc. will announce new one-year results from the Selective estrogens, Menopause, And Response to Therapy [SMART]-5 Phase 3 study of the safety and efficacy of the investigational tissue selective estrogen complex (TSEC) bazedoxifene/conjugated estrogens (BZA/CE) at the 22nd annual meeting of the North American Menopause Society (NAMS), 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 (results recently presented on September 16 at the American Society of Bone and Mineral Research meeting in San Diego, Calif.). 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.
