Feb. 27, 2013 -- The FDA has approved Osphena for treating moderate-to-severe pain during sex in postmenopausal women.
The condition, called dyspareunia, is associated with declining levels of estrogen during menopause, which leads to atrophy of the vulva and vagina, often resulting in pain during sexual intercourse.
Osphena makes vaginal tissue thicker and less fragile, resulting in less pain for women during sex. It is a pill taken with food once daily.
“Dyspareunia is among the problems most frequently reported by postmenopausal women,” says Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Osphena provides an additional treatment option for women seeking relief.”
The safety and effectiveness of Osphena were established in three studies of nearly 2,000 postmenopausal women with symptoms of vulvar and vaginal atrophy.
After 12 weeks of treatment, results from the first two studies showed an improvement in sexual pain among women who took Osphena compared with women who took a placebo.
Results from the third study support the drug's long-term safety.
Osphena is being approved with a boxed warning alerting women and doctors that the drug, which acts like estrogen on vaginal tissues, can stimulate the endometrium and cause it to thicken, the FDA says.
“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 FDA says.
The drug “should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman,” the agency advises.
The boxed warning also notes that about one woman out of a thousand faces a risk of strokes caused by a blood clot or bleeding in the brain. There is also a risk for deep vein thrombosis, a clot that forms in a deep vein, usually in the leg, in about 1.45 women out of a 1,000.
“These rates are considered to represent low risks in contrast to the increased risks of stroke and deep vein thrombosis seen with estrogen-alone therapy,” the FDA says.
Common side effects include hot flushes/flashes, vaginal discharge, muscle spasms, genital discharge, and excessive sweating.