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FDA Approves Low-dose Regimen of PREMARIN Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia – Painful Sexual Intercourse : Agency Grants New Indication for Bothersome Vaginal Symptom Associated with Menopause
Date:11/13/2008

PREMARIN (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE).

COLLEGEVILLE, Pa. (Business Wire EON) November 13, 2008 -- "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," says Gloria Bachmann, M.D., Director of the Women's Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J. and Chief of the OB/GYN service 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.

The approval is based on efficacy results from a multicenter clinical study that included a 12-week randomized, double-blind placebo phase followed by a 40-week open-label phase. Results from the 12-week phase showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily [21 days on/7 days off or twice weekly) significantly improved the dyspareunia score versus placebo at 12 weeks. In this study, dyspareunia was one of the most bothersome symptoms of vulvar and vaginal atrophy. Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women
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