Shionogi receives FDA approval for Osphena to treat women with severe dyspareunia

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

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

Osphena, a pill taken with food once daily, acts like estrogen on vaginal tissues to make them 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 Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Osphena provides an additional treatment option for women seeking relief."

Osphena's safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena's long-term safety in treating dyspareunia.

Osphena is being approved with a boxed warning alerting women and health 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 experience menstruation, and a stimulated endometrium is not normal. Women should see their health care professional if they experience any unusual bleeding as it may be a sign of endometrial cancer or a condition that can lead to it. Osphena should 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 risks in contrast to the increased risks of stroke and deep vein thrombosis seen with estrogen-alone therapy.

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

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