Medicine Approved to Ease Painful Sex

Osphena approved by FDA to ease moderate to severe dyspareunia

(RxWiki News) Pain during sex can be a problem for the 32 million post-menopausal women across the United States. A new medicine could ease the pain.

The FDA recently approved Osphena (ospemifene) to treat women who have moderate to severe pain during sex. The pain comes from vulvar and vaginal atrophy, or thinning and inflammation of the vulva and vagina, after menopause.

"Unusual pain or bleeding? Talk to your doctor immediately."

Severe pain during sex, called dyspareunia, is linked to declining estrogen levels during menopause. Lower levels of the hormone can make tissues in the vagina drier, thinner and more fragile.

Osphena acts like estrogen to thicken and strengthen vaginal tissues, which results in reduced pain during intercourse.

“Dyspareunia is among the problems most frequently reported by postmenopausal women,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, in a press release.

“Osphena provides an additional treatment option for women seeking relief,” she said.

The pill, which is taken once daily with food, was tested for safety and effectiveness in three different studies with almost 1,900 women.

In two of the studies, women who received the Osphena treatment for 12 weeks had less pain during sexual intercourse compared to women who received a fake pill during the trials.

The third study supported the medicine's long-term safety in treating pain during sex.

The medicine will come with a boxed warning label explaining that it can cause the lining of the uterus, called the endometrium, to thicken.

The thickening is normal in fertile women before menstruation. Postmenopausal women no longer have their period and a stimulated endometrium is not normal.

The number of women who experienced a thrombotic and hemorrhagic stroke (0.72 and 1.45 per 1,000 women respectively) in the blood vessels and brain will also be on the warning label.

The FDA stated that these rates are low risks compared to the increased risks for stroke and deep vein thrombosis therapy by taking estrogen therapy alone.

Further, the FDA encourages women to see their doctor for any usual bleeding and suggests that doctors prescribe the medication based on treatment goals and risks for each individual woman.

Review Date: 
February 27, 2013