Nov. 17, 2016 -- A new drug to treat postmenopause-related pain during sexual intercourse has been approved by the U.S. Food and Drug Administration.
The drug Intrarosa (prasterone) is a once-daily vaginal insert and the first FDA-approved product to contain the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA).
In two 12-week clinical trials that included 406 postmenopausal women ages 40-80, Intrarosa was found to be more effective than a placebo at reducing the severity of pain during sexual intercourse, according to the FDA.
During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as vulvar and vaginal and atrophy (VVA), leading to symptoms such as pain during sexual intercourse.
"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," Dr. Audrey Gassman, deputy director of the FDA's Division of Bone, Reproductive, and Urologic Products, said in an agency news release.
Intrarosa is marketed by Endoceutics Inc. of Quebec, Canada.