FDA approves new drug for postmenopausal women experiencing pain during sex

The US Food and Drug Administration approved a new treatment for women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

Intrarosa (prasterone) is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). The product was developed and will be marketed by privately-held Quebec, Canada-based biotech firm EndoCeutics.

"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, 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," she added.