The FDA has approved a medication to help relieve the moderate to severe pain some women may experience during sexual intercourse because of vulvar and vaginal atrophy (VVA) after menopause.
The drug, marketed as Intrarosa, is the first FDA-approved product containing the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA). It is used as a once-daily vaginal insert.
“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” Audrey Gassman, MD, deputy director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
In two 12-week trials, 406 healthy postmenopausal women aged 40 to 80 years were randomized to receive Intrarosa or a placebo vaginal insert. Compared with the placebo, Intrarosa reduced the severity of pain during intercourse. During four 12-week safety trials, the most common adverse reactions were vaginal discharge and abnormal Pap smear results.
The FDA noted that 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.
read more at JAMA