One of the most troubling side effects of menopause—painful sex—now has a new treatment approved earlier this week by the US Food and Drug Administration. It’s a pill called ospemifene (Osphena), and it acts like an estrogen on vaginal tissues to make them thicker and less fragile.
A lack of estrogen during menopause causes these tissues to become dry and thin, which can make intercourse very painful for some women.
“Dyspareunia is among the problems most frequently reported by postmenopausal women,” Dr. Victoria Kusiak, an FDA deputy director said in a statement. “Osphena provides an additional treatment option for women seeking relief.”
The agency based its approval on three clinical studies of 1,889 postmenopausal women with symptoms of vaginal dryness. After 12 weeks of treatment, women had a significant improvement in their symptoms compared to those who took a placebo.
Common side effects include hot flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating.
A year-long safety study found few risks associated with the drug. It doesn’t, for instance, cause an increase in breast cancer risk, which has been associated with hormone replacement therapy.
Osphena will, however, have a boxed warning alerting women and doctors that the drug could cause the uterine lining to thicken, possibly increasing the risk of endometrial cancer. Women who experience vaginal bleeding should alert their doctor and may need further evaluation like an ultrasound and uterine biopsy.
“The FDA has been very conservative when it comes to approving new drugs for women’s mid-life quality of life due to safety concerns, so it’s very exciting to see a new one approved,” Dr. Jan Shifren, director of the Vincent menopause program at Massachusetts General Hospital, said in an interview.
Up to 60 percent of women experience vaginal dryness around the time of menopause that makes sex less pleasurable or downright painful. Unlike hot flashes and night sweats which tend to wane over time, vaginal dryness often gets worse and worse, said Shifren—especially if a woman becomes less sexually active.
“It’s really important for women to act on this problem early because it’s much harder to treat later one,” Shifren added, as tissues continue to atrophy.
Over-the-counter remedies like vaginal moisturizers, applied several times a week, or lubricants during sex are the first line of treatment, she said, along with sex itself, which helps keep vaginal tissues healthy.
If those don’t work, prescription low-dose topical estrogens, in a cream, suppository, or ring form, can be applied directly to vaginal tissues. Shifren said she’ll advise her patients to consider the new pill—whose price hasn’t yet been announced by the manufacturer—if the topical agents don’t work or if a woman doesn’t like using them.
Since the new pill hasn’t been compared to older products in head to head trials, it’s not known whether it’s safer or more effective.