Opemifen Chinese Description

English drug name:

Osphena (Ospemifene Tablets)

Chinese drug name:

Opemifenetablets

Manufacturer:

Yanyeyi Company

Drug introduction

On February 26, 2013, the US Food and Drug Administration (FDA) approved Osphena (ospemifene) treatment of women with moderate to severe dyspareunia, a symptom of menopausal vulva and vaginal atrophy.

Sexual pain is a concomitant decrease in the hormone levels of estrogen during menopause. Lower estrogen may thin the vaginal tissue, dry out and become more fragile, causing pain during intercourse.

Osphena, a drug that is orally administered to food once a day, acts like estrogen on the vaginal tissue to make them thicker, and less fragile, causing women to suffer from reduced amounts of sexual intercourse.

Victoria Kusiak, MD, deputy director of the Drug Evaluation and Research Center at the FDA's Center for Drug Evaluation and Research, said: "Sexual pain is the most frequently reported problem in postmenopausal women, and Osphena offers another treatment option for women seeking relief."

Three clinical studies in 1889 postmenopausal women with vulvar and vaginal atrophy identified the safety and efficacy of Osphena. Women are randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, the results from the first two trials showed a statistically significant improvement in statistically significant pain in Osphena-treated women compared with women receiving placebo. The results from the third study support the long-term safety of treatment for sexual pain.

Osphena is being approved to have a black box warning to remind women and health care professionals that the drug acts like estrogen on vaginal tissue and has been shown to stimulate the lining of the uterus (endometrium) and thicken it. In fertile women, this thickening of the endometrium occurs monthly before menopause. Postmenopausal women will never have menstruation, and the stimulated endometrium is not normal. Women who regularly experience unusual bleeding should seek out their health care professional because they may be signs of endometrial cancer or a condition that causes endometrial cancer. Osphena prescriptions should be consistent with individual women's shortest time and treatment goals and risks.

The black box warning also states the incidence of thrombotic and hemorrhagic stroke (0.72 and 1.45 per thousand women, respectively) and the incidence of deep vein thrombosis (1.45 per thousand women). These rates represent a low risk of the opposite of estrogen therapy alone with an increased risk of stroke and deep vein thrombosis.

The most commonly reported side effects during clinical trials include hot flashes, vaginal discharge, muscle spasms, genital discharge, and excessive sweating.

Osphena is listed by Shionogi Inc., a saltfield-based pharmaceutical company based in New Jersey.