FDA Actions

The FDA has approved prasterone to treat women with moderate to severe dyspareunia due to menopause-related vulvar and vaginal atrophy. The drug is the first FDA-approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone is administered as a once-daily vaginal insert. Efficacy was established in two 12-week, placebo-controlled trials of 406 healthy women, 40-80 years of age with moderate to severe symptoms. Compared to placebo, the prasterone vaginal insert reduced the severity of pain experienced during sexual intercourse. Safety was established in four 12-week, placebo-controlled trials on one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal pap smears. Prasterone vaginal insert is marketed as Intrarosa.