ChemPharmSou(Beijing) Technology Co., Ltd.

February 26, 2013 -- The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain duri≤ng sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.

Dyspareunia is a condition associated with declining levels of estrogen hormone✘s during menopause. Less estrogen can make vaginal tissues thinner, drier and m ore fragile, resulting in pain during sexual intercourse.

Osphena, a pill taken with food once daily, acts like estrogen on vaginal tissues to make theγm thicker and less fragile, resulting in a reduction in the amount of pain women experience £with sexual intercourse.
 

“Dyspareunia is among the problems most frequently reported ✔by postmenopausal women,” said Victoria Kusiak, M.D., deputy director of the Office of Drγug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “O₹sphena provides an additional treatment option for women seeking relief.”

Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postme÷nopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receiveβ Osphena or a placebo. After 12 weeks of treatment, results frΩom the first two trials showed a statistically significant impr∑ovement of dyspareunia in Osphena-treated women compared with women receiving pla₽cebo. Results from the third study support Osphena’s long-term safλety in treating dyspareunia.

Osphena is being approved with a boxed warning alerting women and heal¥th care professionals that the drug, which acts like estrogen on vaginal tissues, has shown ♣it can stimulate the lining of the uterus (endometrium) and cause it to thicken. In♣ fertile women, this thickening of the endometrium occurs ​monthly before menstruation. Postmenopausal women no longer ex♠perience menstruation, and a stimulated endometrium ∑is not normal. Women should see their health care professional if they experience any unusual blee♠ding as it may be a sign of endometrial cancer or a condition that can lead to it. Osphena shoul∏d be prescribed for the shortest duration consistent with treatment goals and risks for ↑the individual woman.

The boxed warning also states the incidence rates of thrombotic and hemorrhagic★ strokes (0.72 and 1.45 per thousand women, respectively) and the incidence rate of> deep vein thrombosis (1.45 per thousand women). These rates are considered to represent low risk✔s in contrast to the increased risks of stroke and deep vein thrombosis seen with γestrogen-alone therapy.

Common side effects reported during clinical trials  included hot flush/flashes, vaginal discharge, muscle spasms, geni₩tal discharge and excessive sweating.

Osphena is marketed by Florham Park, N.J.-based Shionogi, Inc.

Source: FDA

Posted: February 2013