Divigel(R) (estradiol Gel) 0.1 Percent Offers Lowest Approved Dose Of Estradiol For Treatment Of Moderate To Severe Hot Flashes

Medical specialists from
around the country will gather this week to discuss the latest research in
obstetrics and gynecology, and menopause and estrogen therapy will be among
the information presented.


"Estrogen therapy continues to be the gold standard for the management
of hot flashes, the most common physical sign of menopause," said Dr. Ricki
Pollycove, fellow, American College of Obstetrics and Gynecology and
clinical faculty member, University of California, San Francisco. "However,
because of misconceptions that still exist today due to the influx of
conflicting information that has emerged since the Women's Health
Initiative Study, women may not be aware that advances in low-dose hormone
therapies exist."



In June 2007, the U.S. Food and Drug Administration (FDA) approved
Divigel(R) (estradiol gel) 0.1 percent, the lowest approved dose of
estradiol available for the treatment of moderate to severe hot flashes
associated with menopause. Guidelines from the North American Menopause
Society (NAMS) indicate that estrogen hormone therapy should be used at the
lowest effective dose for the shortest amount of time.



"Transdermal estrogen therapies, such as Divigel(R), are emerging as an
effective and safe mode of treatment," said Dr. Pollycove.



The estrogen in Divigel(R) is derived from plant sources and is
bioidentical to the primary estrogen produced by a woman's ovaries before
menopause. Certain older oral estrogen therapies contain conjugated
estrogens derived from the urine of pregnant mares. Divigel(R) is a
quick-drying gel that is odorless when dry, and is available in convenient,
individual-use packets. One packet of gel is applied daily to an area that
measures approximately 5 x 7 inches on the thigh, the smallest application
area compared to all other available gel or lotion estrogen products. After
the gel is applied, it absorbs directly into the bloodstream without having
to pass through the liver. Divigel(R) also offers dosing flexibility with
three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and
1.0 mg estradiol/day) to individualize treatment for each woman.



Important Safety Information for Patients



The following are not all the possible risks for Divigel(R). Please
read the full Patient Information leaflet and talk to your healthcare
provider.



Estrogens increase the chance of getting cancer of the uterus. Report
any unusual vaginal bleeding right away while you are taking estrogens.
Vaginal bleeding after menopause may be a warning sign of cancer of the
uterus (womb). Your healthcare provider should check any unusual vaginal
bleeding to find out the cause. In general, the addition of a progestin is
recommended for women with a uterus to reduce the chance of getting cancer
of the uterus.
















Do not use estrogens, with or without progestins, to prevent heart
disease, heart attacks, or strokes. Using estrogens, with or without
progestins, may increase your chance of getting heart attacks, strokes,
breast cancer, and blood clots.



Do not use estrogens, with or without progestins, to prevent dementia.
Using estrogens, with or without progestins, may increase your risk of
dementia.



Do not use estrogen products, including Divigel(R), if you have unusual
vaginal bleeding, currently have or have had certain cancers, had a stroke
or heart attack in the past year, currently have or have had blood clots,
currently have or have had liver problems, are allergic to any Divigel(R)
ingredients, or think you may be pregnant.



The most common side effects for all estrogen products are headache,
breast pain, irregular vaginal bleeding or spotting, stomach/abdominal
cramps and bloating, nausea and vomiting, and hair loss. Less common but
serious side effects include breast cancer, cancer of the uterus, stroke,
heart attack, blood clots, dementia, gallbladder disease and ovarian
cancer.



In Divigel(R) clinical trials, the most common side effects were
inflammation of the nasal passages and pharynx, upper respiratory tract
infection, vaginal yeast infection, breast tenderness and vaginal bleeding.
Call your healthcare provider right away if you have any symptoms that
concern you.



Estrogen products should be used at the lowest dose possible for your
treatment and only as long as needed. You and your healthcare provider
should talk regularly about whether you still need treatment with
Divigel(R).



Orion Corporation (OMX: ORNAV, ORNBV) has a licensing agreement with
Upsher-Smith Laboratories for the development of Divigel(R) in the United
States. Orion is one of the leading pharmaceutical companies in northern
Europe through its development, manufacturing and marketing of
pharmaceuticals, active pharmaceutical ingredients and diagnostic tests for
global markets. The core therapeutic areas in Orion's product and research
strategy are central nervous system disorders, cardiology, critical care
and hormonal and urological therapies.



Upsher-Smith Laboratories, Inc. is a rapidly growing pharmaceutical
company that manufactures and markets both prescription and consumer
products. Privately held since 1919, the company strives to recognize the
unmet healthcare needs of our customers. Upsher-Smith prides itself in
providing safe, effective, and economical therapies to the ever-challenged
healthcare environment. For additional information about Upsher-Smith,
visit upsher-smith.


Upsher-Smith Laboratories, Inc.

upsher-smith


View drug information on Estradiol Transdermal System.