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.
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.
Source: Pfizer, USA