FDA Approves PREMARIN Vaginal Cream
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).
"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 in either regimen.
"This new indication for PREMARIN Vaginal Cream, with a low volume of 0.5 g 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," says Eileen Helzner, M.D., Assistant Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.
PREMARIN Vaginal Cream is only available by prescription.
Important Safety Information
What is the most important information you should know about PREMARIN Vaginal Cream (a cream of estrogens)?
* Estrogens may increase the chances of getting cancer of the uterus.
* Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find the cause.
* Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
* Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream.
PREMARIN Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat painful intercourse caused by menopausal changes of the vagina.
PREMARIN Vaginal Cream should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in PREMARIN Vaginal Cream, or think you may be pregnant.
The most commonly reported side effects of PREMARIN Vaginal Cream included headache, infection, abdominal pain, accidental injury, and vaginitis.