FDA Approves Low-dose Regimen Of PREMARIN
Vaginal
Cream To Treat Moderate To Severe Postmenopausal Dyspareunia
or Painful Sexual Intercourse
Medicalnewstoday.com, Nov. 14, 2008. PREMARIN(R)
(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(R) 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.
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