It’s a common problem among postmenopausal women – painful sexual intercourse due to thinner, drier, more fragile vaginal tissues. To help the roughly 32 million women with this condition, the Food and Drug Administration (FDA) has approved a new drug called Osphena.
Dyspareunia – the medical name for painful intercourse – is associated with postmenopausal declining estrogen levels after menopause; this in turn affects vaginal tissues. “Dyspareunia is among the problems most frequently reported by postmenopausal women,” Victoria Kusiak, M.D., with the FDA’s Center for Drug Evaluation and Research, said in a statement. “Osphena provides an additional treatment option for women seeking relief.”
Although there are estrogen creams and suppositories that can help women with vaginal tearing and dryness, Osphena is less messy and not estrogen-based, for women wary of using the hormone. According to the FDA, Osphena, a pill taken once daily with food, acts like estrogen on the tissues, to make them thicker and less fragile.
Of course, things are never quite as simple as just taking a pill. Osphena comes with a black box warning on the label – the most serious kind – alerting women to an increased risk of strokes, deep vein thrombosis, and thickening of the endometrium (the lining of the uterus).
The FDA cautions that “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.”
The pill also hasn’t been tested on women who have had breast cancer, so they’re warned not to take it either. For all these reasons, the FDA says Osphena should be prescribed “for the shortest duration consistent with treatment goals and risks for the individual woman.”
Gynecologist David Portman, M.D., director of the Columbus Center for Women’s Health Research in Ohio, was the lead researcher in Osphena’s safety and effectiveness trials. He says women enrolled in the trials reported benefits by the fourth week on the drug, though he adds that “it is not known when or if symptoms recur after discontinuing therapy.”
The hope is that “once sex becomes less painful with treatment,” patients and partners will be able to have regular intercourse, which “is beneficial for maintaining vaginal health,” he adds.
A spokeswoman for Shionogi Inc., the maker of Osphena, told the Times that the drug is expected to become available in the U.S. in June, but that its price has not yet been set.
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