FDA approves prescription Premarin cream for painful intercourse in women

COLLEGEVILLE, Pa. Premarin (conjugated estrogens) Vaginal Cream (0.5 grams) has been approved by the Food and Drug Administration to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) Wyeth Pharmaceuticals announced Thursday.

“This approval is welcome news, especially when you consider that more than one in four untreated postmenopausal women experience dyspareunia, a symptom of vulvar and vaginal atrophy, which typically does not subside without treatment,” said Gloria Bachmann, director of the Women’s Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School and chief of OB/GYN at the teaching hospital.

Premarin Vaginal Cream is the first vaginal estrogen therapy indicated for the treatment of moderate to severe dyspareunia due to menopause. A low-volume regimen of Premarin Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause.

“This new indication for Premarin Vaginal Cream, with a low volume of 0.5 grams and two different dosing regimens—21 days on/7 days off or twice weekly—gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause,” said Eileen Helzner, assistant vice president of global medical affairs, Wyeth Pharmaceuticals.

Premarin Vaginal Cream is only available by prescription.