FDA approves Intrarosa for moderate to severe pain during intercourse

Intrarosa (prasterone), which is designed for women who experience moderate to severe pain during sex, has been approved by the U.S. Food and Drug Administration.
Women experience this type of pain due to vulvar and vaginal atrophy (VVA) caused by menopause. With the FDA’s approval, Intrarosa became the first medication that contains prasterone approved by the FDA.
"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," Deputy Director of the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products Dr. Audrey Gassman said. "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA."
VVA is caused when vaginal tissues see a decline in the levels of estrogen, which leads to pain during sex.
Intrarosa’s effectiveness treating this condition was proved during two, 12-week clinical trials. The trial studied 406 healthy, postmenopausal women -- ranging from ages 40 to 80 -- who were experiencing moderate to severe pain during sex. The safety of Intrarosa was also established during four, 12-week trials and one open-label study lasting 52 weeks.