On November 17th, 2016 the U.S. Food and Drug Administration (FDA) approved Intrarosa® (prasterone) manufactured by Quebec-based Endoceutics Inc.to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa® is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). During menopause, levels of estrogen decline in vaginal tissues. This may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse. A few important facts about dyspareunia pain include but are not limited to the following:
- The pain may be superficial or deep.
- It may result from vaginal dryness or disorders of the genital organs.
- The diagnosis is based on symptoms and a pelvic examination.
- Anesthetic ointments, lubricants, exercises to relax pelvic muscles, or a change in the position for intercourse may help.
- The cause, if identified, is treatable.
The pain may be superficial, felt in the area around the opening of the vagina (genital area or vulva). Or the pain may be deep, felt within the pelvis when the penis or a dildo is thrust further inside. The pain may be burning, sharp, or cramping. Pelvic muscles tend to become tight, which increases the pain, whether it is superficial or deep. Pain, including dyspareunia, is greatly affected by emotions. For example, minor discomfort may feel like severe pain after a traumatic sexual experience, such as rape. Anger toward a sex partner, fear of intimacy or pregnancy, a negative self-image, or a belief that the pain will never go away may make the pain feel worse.
“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in 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 clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.
The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.
Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.
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