Drug contained in a once-daily vaginal insert
THURSDAY, Nov. 17, 2016 (HealthDay News) — Intrarosa (prasterone) has been approved by the U.S. Food and Drug Administration to treat women who have moderate-to-severe pain during sexual intercourse caused by postmenopausal vulvar and vaginal atrophy (VVA).
The product, contained in a once-daily vaginal insert, is the first approved to include the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA), the agency said Thursday in a news release.
The product’s effectiveness was established in two 12-week clinical trials involving 406 postmenopausal women, aged 40 to 80. The most common adverse reactions included vaginal discharge and abnormal Pap smear.
“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” Audrey Gassman, M.D., 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 (CDER), said in a statement. “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”
Intrarosa is marketed by Endoceutics Inc., based in Quebec, Canada.
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