New Study Shows Enjuvia Significantly Reduced 'Sleep Time' Awakenings Caused by Hot Flashes in Postmenopausal Women
SAN FRANCISCO, May 18 /PRNewswire/ -- Teva Women's Health, Inc.
today presented data that demonstrated patients treated with a
standard or low dose of ENJUVIA® (synthetic conjugated
estrogens, B) tablets experienced statistically significant
reductions in how often they were awakened at night by hot flashes
compared to patients treated with placebo. The data was presented
today at the 58th Annual Clinical Meeting of the American College
of Obstetricians and Gynecologists in San Francisco.
Hot flashes, caused by menopausal hormone changes, occur in as
many as 85 percent of menopausal women, and can be severe enough to
negatively impact sleep. The prevalence rate of sleep problems
among perimenopausal women and postmenopausal women varies from 31
to 45 percent.
This study evaluated the effectiveness of ENJUVIA (0.3mg and
0.625mg doses) over a 12-week treatment period in reducing the
frequency of nighttime sleep awakenings caused by hot flashes in
highly symptomatic women. These women were defined as experiencing
at least three nighttime awakenings per night at baseline. The
study met its primary endpoint of significantly reducing the number
of awakenings in both dosing arms with the higher dose achieving a
greater mean reduction of 4.56 awakenings per week (p<0.001)
than the lower dose (3.55 awakenings per week, p=0.004) relative to
placebo. The study did not meet its secondary endpoint of
significantly improving individual sleep quality or overall daytime
sleepiness as measured by the Stanford Sleepiness Scale
"Sleep disruptions due to menopausal symptoms can adversely
impact a woman's quality of life," said lead investigator James H.
Liu, M.D., Arthur H. Bill Professor and Chair at the Department of
Obstetrics and Gynecology at Case Western Reserve University School
of Medicine in Cleveland. "These results are encouraging and show
that highly symptomatic postmenopausal women who are repeatedly and
routinely awakened by hot flashes night after night can find relief
with ENJUVIA even at the lowest dose to regain better control over
their sleep time."
Patients enrolled in the higher dose study arm showed
statistically significant improvement in reduction of the frequency
of awakenings starting at week four, and at weeks eight and 12;
while patients in the lower dosing arm demonstrated statistically
significant improvement at weeks eight and 12 compared to
About the Study
The study, conducted at 19 sites in the United States, was
designed as a double-blind, placebo-controlled trial with three
treatment groups (0.3 mg SCE-B, n= 53; 0.625 mg SCE-B, n=52; or
matching placebo, n=52).
All participants were naturally or surgically postmenopausal
women, with or without a hysterectomy, aged 30 to 65 years. In
order to be accepted into the study, each participant, during a
minimum qualification period of two weeks, must have experienced on
average at least seven daily (or 50 weekly) moderate-to-severe hot
flashes, and at least three disruptions per night due to hot
flashes over seven consecutive days.
Over the course of the study, patients were evaluated during
clinic visits at weeks two, four, eight and 12, during which time
frequency of nighttime hot flashes was recorded in daily written
diaries. Each participant was asked to record the time the pills
were taken, as well as the number of "sleep time" awakenings they
attributed to hot flashes.
Menopause is the time in a woman's life when the menstrual
period ceases and the ovaries permanently stop releasing eggs.
Menopause is considered complete when a woman has been without her
period for a full year. While some women experience no menopausal
symptoms, others suffer severe symptoms that may require treatment.
Vasomotor symptoms (hot flashes and night sweats) and vaginal
atrophy are the most common menopausal symptoms. Although the
majority of women experience "natural" or spontaneous menopause,
some women may experience menopause due to a medical intervention
such as surgery, chemotherapy or radiation. For more information
about menopause, please visit www.CopeWithMenopause.com.
Important Safety Information about ENJUVIA® (synthetic
conjugated estrogens, B)
Important health information you should know when taking
estrogens like ENJUVIA: Estrogens increase the risk for cancer of
the uterus (womb). If you experience persistent or recurring
vaginal bleeding while taking estrogens let your doctor know right
away, as this could be a warning sign for cancer. Your doctor
should check for the cause of any unusual vaginal bleeding after
Estrogens (alone, or in combination with progestins) should not
be used to prevent heart disease, heart attacks, strokes, or
Estrogens (alone or in combination with progestins) may increase
the risk of heart attack, stroke, blood clots, and breast cancer.
Estrogens (alone or in combination with progestins) may increase
your risk of dementia, based on a study of women age 65 or older.
Because of these risks, estrogens should be used at the lowest dose
for the shortest period of time. You and your doctor should talk
regularly to determine whether you still need treatment with
Who should not use ENJUVIA? Do not use ENJUVIA if you: -- May be pregnant -- Have had a stroke or heart attack in the past year -- Have unusual vaginal bleeding -- Are allergic to ENJUVIA or any of its ingredients -- Have a history of certain cancers, blood clots, or liver problems What are the common side effects with ENJUVIA?
You may experience headache, breast pain, irregular vaginal
bleeding or spotting, stomach/abdominal cramps and bloating, nausea
and vomiting, or hair loss.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
Women and healthcare providers who would like to learn more
about ENJUVIA, including full prescribing information, should visit
About Teva Women's Health, Inc.
Teva Women's Health, Inc., (formerly Duramed Pharmaceuticals,
Inc.) which develops and markets proprietary pharmaceutical
products in North America, focuses primarily on products for women
and emphasizes the development and marketing of products for
reproductive and menopausal needs.
Teva Women's Health, Inc., is a subsidiary of Teva
Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd.
, headquartered in Israel, is among the top 15 pharmaceutical
companies in the world and is the leading generic pharmaceutical
company. The company develops, manufactures and markets generic and
innovative pharmaceuticals and active pharmaceutical ingredients.
Over 80 percent of Teva's sales are in North America and Western
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
are based on management's current beliefs and expectations and
involve a number of known and unknown risks and uncertainties that
could cause our future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to successfully develop and
commercialize additional pharmaceutical products, the introduction
of competing generic equivalents, the extent to which we may obtain
U.S. market exclusivity for certain of our new generic products and
regulatory changes that may prevent us from utilizing exclusivity
periods, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that
relating to the generic versions of Neurontin®, Lotrel® and
Protonix®, the extent to which any manufacturing or quality
control problems damage our reputation for high quality production,
the effects of competition on sales of our innovative products,
especially Copaxone® (including potential generic and oral
competition for Copaxone®), the impact of continuing
consolidation of our distributors and customers, our ability to
identify, consummate and successfully integrate acquisitions,
interruptions in our supply chain or problems with our information
technology systems that adversely affect our complex manufacturing
processes, intense competition in our specialty pharmaceutical
businesses, any failures to comply with the complex Medicare and
Medicaid reporting and payment obligations, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation, adverse effects of
political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, increased
government scrutiny in both the U.S. and Europe of our agreements
with brand companies, dependence on the effectiveness of our
patents and other protections for innovative products, our ability
to achieve expected results through our innovative R&D efforts,
the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals,
uncertainties surrounding the legislative and regulatory pathway
for the registration and approval of biotechnology-based products,
potentially significant impairments of intangible assets and
goodwill, potential increases in tax liabilities resulting from
challenges to our intercompany arrangements, our potential exposure
to product liability claims to the extent not covered by insurance,
the termination or expiration of governmental programs or tax
benefits, current economic conditions, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in this
report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
Source: Teva Women's Health, Inc.
CONTACT: Dave Schemelia, HealthStar PR, +1-609-468-9325,
Web Site: http://www.enjuvia.com/
Posted: May 2010