FDA ok’s drug to treat pain during sex

The FDA has approved a selective estrogen receptor modulator (SERM) for treating pain associated with sexual intercourse in postmenopausal women.

Taken daily in oral tablet form, ospemifene (Osphena) targets vulvar and vaginal atrophy resulting from menopause, which is the underlying cause of dyspareunia, or pain during sex.

The treatment, however, will come with a boxed warning stating that it may thicken the uterine lining, with the concern that unusual bleeding may be a sign of endometrial cancer or a condition that can lead to it.

The boxed warning also will caution about the risk of thrombotic and hemorrhagic strokes (occurring in 0.72 and 1.45 per 1,000 women, respectively), and the risk of deep vein thrombosis (occurring in 1.45 per 1,000 women).

These rates are considered low risks in relation to the increased risks of stroke and deep vein thrombosis seen with estrogen-only therapy, the FDA noted.

Still, the agency said the drug should be prescribed for the shortest duration possible.

The safety and efficacy of ospemifene were established in three clinical trials with a total enrollment of 1,889 postmenopausal women with vulvar and vaginal atrophy.

Two 12-week studies showed that those on the drug had significant improvements in dyspareunia compared with those on placebo. A third study vouched for its longer-term safety, though FDA did not note exactly how long the trial ran.

Common side effects of ospemifene include hot flashes, vaginal discharge, muscle spasms, genital discharge, and excessive sweating.

Ospemifene is marketed by Shionogi, Inc., of Florham Park, N.J., which licenses it from QuatRx.