FDA Green-lights Intrarosa for Dsypareunia in Menopause
FDA approves Intrarosa for dyspareunia.
Intrarosa (prasterone, Endoceutics Inc) recently received approval from the US Food and Drug Administration (FDA) to treat moderate to severe pain during sexual intercourse (dyspareunia)—a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
According to an agency press release, Intrarosa is the first FDA-approved product containing prasterone, which is also known as dehydroepiandrosterone (DHEA).
Researchers evaluated the efficacy of the once-daily vaginal insert in 2 12-week placebo-controlled clinical trials involving 406 healthy postmenopausal women aged 40 to 80 years who reported moderate to severe pain during sexual intercourse as the most bothersome symptom of VVA. They were randomly assigned to prasterone or a placebo vaginal insert. Results showed that the severity of pain during sexual intercourse was reduced more with prasterone than placebo.
Safety was established in 4 12-week, placebo-controlled trials and 1 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.
In the release, the FDA also stated that although some dietary supplements contain DHEA, the safety and efficacy of those products have not been established for diagnosing, curing, mitigating, treating, or preventing any disease.
During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as 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," Audrey Gassman, MD, 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), said in the release. "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA."
- FDA approves Intrarosa for postmenopausal women experiencing pain during sex [press release]. Silver Spring, MD: FDA Newsroom; November 17, 2016. Accessed November 22, 2016.