FDA approves Osphena for dyspareunia in postmenopausal women

The FDA approved ospemifene (Osphena, Shionogi, Inc) for the treatment of moderate to severe dyspareunia, or pain during sexual intercourse, in postmenopausal women.

Dyspareunia is a symptom associated with vulvar and vaginal atrophy due to menopause, according to an FDA press release. The condition is associated with a decline in estrogen hormones during menopause.

Ospemifene, taken once daily with food is believed to work by acting like estrogen, creating thicker and less fragile vaginal tissues. This provides a decrease in the pain associated with sexual intercourse, according to the press release.

The approval comes after three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. The patients were randomly assigned to ospemifene or placebo. Following 12 weeks of therapy, the first two trials yielded statistically significant improvements in dyspareunia among those who were assigned ospemifene compared with those who were assigned placebo. Results from the third study demonstrate long-term safety data of ospemifene in treating dyspareunia.

According to the press release, ospemifene should be prescribed for the shortest duration consistent with treatment goals and risks for individual patients.

The drug’s boxed warning includes the incidence rates of thrombotic (0.72 per 1,000 women) and hemorrhagic strokes (1.45 per 1,000 women) and the incidence rate of deep vein thrombosis (1.45 per 1,000 women). These risks are considered low compared with the increased risk for stroke and deep vein thrombosis recognized in estrogen-only therapy, according to the press release.

Adverse events in the clinical trials included hot flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating.