FDAnews

OSPEMIFENE FOUND EFFECTIVE IN BREAST CANCER PREVENTION

Recent study results have shown that use of the drug Ospemifene in combination with other anti-estrogens for vaginal atrophy reduces the incidence of breast cancer. The study has been proved in a mouse model and researchers are planning for a clinical trial.

Ospemifene is a selective estrogen receptor modulator, and is an effective anti-estrogen - like tamoxifen and raloxifen - that is used in the prevention and treatment of breast cancer that binds to estrogens. Ospemifene is now being developed by QuatRx Pharmaceuticals. The drug is expected to enter Phase III clinical testing in the U.S. early next year for the treatment of vaginal atrophy, a common condition among postmenopausal women.

The advantage of Ospemifene over tamoxifen and raloxifen is due to its reduced side-effects as raloxifen can cause hot flashes, insomnia and blood clots. Tamoxifen can cause endometrial cancer in patients undergoing tamoxifen therapy for breast cancer. But ospemifene has a unique estrogen-like effect on the vagina, yet a neutral effect on the endometrium, or lining of the uterus, and no aggravation or initiation of hot flashes.