FDA approves agent for postmenopausal dyspareunia

The FDA has approved ospemifene (Osphena) to treat women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

Ospemifene, an oral estrogen agonist/antagonist with tissue selective effects, is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause, according to its marketer, Shionogi Inc.

"Dyspareunia is among the problems most frequently reported by postmenopausal women," said Victoria Kusiak, MD, of the FDA’s Center for Drug Evaluation and Research. "Osphena provides an additional treatment option for women seeking relief."

The drug’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 ospemifene or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in treated women compared with women receiving placebo. Results from the third study support ospemifene’s long-term safety in treating dyspareunia, the FDA said in a statement.

The drug comes with a boxed warning indicating that ospemifene may stimulate the lining of the endometrium and cause it to thicken. 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.

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