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FDA approves Intrarosa for postmenopausal women experiencing pain during sex


The U.S. Food and Drug Administration permitted Intrarosa (prasterone) to deal with women experiencing average to extreme pain during sexual activity (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), on account of menopause. Intrarosa is the primary FDA permitted product containing the lively ingredient prasterone, which is also referred to as dehydroepiandrosterone (DHEA).


During menopause, ranges of estrogen decline in vaginal tissues, which can trigger a situation generally known as VVA, resulting in signs reminiscent of pain during sexual activity.


“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” stated Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) within the Office of Drug Evaluation III within the FDA’s Center for Drug Evaluation and Research (CDER). “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”


Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled medical trials of 406 wholesome postmenopausal women, 40 to 80 years of age, who recognized average to extreme pain during sexual activity as their most bothersome symptom of VVA. Women have been randomly assigned to obtain Intrarosa or a placebo vaginal insert. Intrarosa, when in comparison with placebo, was proven to scale back the severity of pain skilled during sexual activity.


The security of Intrarosa was established in 4 12-week placebo-controlled trials and one 52-week open-label trial. The commonest hostile reactions have been vaginal discharge and irregular Pap smear.


Although DHEA is included in some dietary dietary supplements, the efficacy and security of these merchandise haven’t been established for diagnosing, curing, mitigating, treating or stopping any illness.


Intrarosa is marketed by Quebec-based Endoceutics Inc.

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