The FDA has approved prasterone (Intrarosa, Endoceutics, Inc.) to treat women experiencing moderate-to-severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA-approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).
During menopause, levels of estrogen decline in vaginal tissues, which may cause VVA.
“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, MD, Deputy Director of the Division of Bone, Reproductive, and Urologic Products in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”
The efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate-to-severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared with placebo, was shown to reduce the severity of pain experienced during sexual intercourse.
The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.
Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating, or preventing any disease.
Source: FDA and Endoceutics, Inc.; November 17, 2016.