WOODCLIFF LAKE, N.J., Oct. 2 /PRNewswire-FirstCall/ -- Duramed
Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:
BRL), announced today the launch of its marketing campaign for ENJUVIA(TM)
for the treatment of moderate-to-severe vaginal dryness and pain with
intercourse, symptoms of vulvar and vaginal atrophy associated with
menopause. ENJUVIA(TM) is the first and only oral estrogen approved by FDA
for the treatment of these specific symptoms associated with vaginal
atrophy. ENJUVIA, a plant-derived oral estrogen therapy is already approved
for the treatment of moderate-to- severe vasomotor symptoms (hot flashes
and night sweats) associated with menopause.
The launch of this new indication comes in conjunction with the North
American Menopause Society annual meeting, October 3-6.
According to the North American Menopause Society (NAMS), an estimated
10- 40 percent of post-menopausal women suffer from symptoms related to
vaginal atrophy (1). Two of the most common symptoms of vaginal atrophy are
vaginal dryness and pain with intercourse (2). The symptoms of vaginal
atrophy are most commonly associated with the diminished estrogen levels
that accompany menopause (1). If left untreated, vaginal atrophy may result
in years of discomfort (1).
"ENJUVIA has been shown in clinical studies to provide relief of
moderate to severe vaginal dryness and pain with intercourse, symptoms of
vulvar and vaginal atrophy associated with menopause. ENJUVIA's indication
for the treatment of these moderate to severe vaginal symptoms associated
with menopause affords women and healthcare professionals a new and
effective treatment option for two of the most common symptoms associated
with vaginal atrophy," stated James A. Simon, M.D., Clinical Professor of
Obstetrics and Gynecology at George Washington University and Medical
Director, Women's Health & Research Consultants. "There is no
one-size-fits-all treatment for menopausal symptoms and women with symptoms
should talk to their healthcare professional about finding a therapy that
is right for them. For moderate to severe hot flashes and night sweats and
moderate to severe vaginal atrophy, hormone therapy may be appropriate. If
taking estrogen only for the symptoms of vaginal atrophy, topical treatment
should be considered."
In addition to launching the new indication, the 0.9 mg tablet
strength, approved by FDA in April, will now be added to the existing range
of tablet dosing strengths which also includes 0.3 mg, 0.45 mg, 0.625 mg
and 1.25 mg dosing strengths. This new dosage strength provides additional
options for healthcare professionals and patients initiating oral estrogen
therapy. Patients should be started at the lowest approved dose of 0.3 mg
of ENJUVIA daily. Subsequent dosage adjustment (which will differ depending
on the indication) and periodic reassessment may be made based upon the
individual patient response. When prescribed solely for the treatment of
symptoms of vulvar and vaginal atrophy, topical products should be
considered.
Sources
(1) Menopause: The Journal of the North American Menopause Society
Vol. 14, No.3 pp. 357-358
(2) Bachman Ga, Ebert GA, Burd ID. Vulvovaginal Complaints. In: Lobo RA,
ed. Treatment of the Postmenopausal Woman: Basic and Clinical
Aspects. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins;
1999:195-201
About Menopause
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 require treatment. Vasomotor symptoms (night sweats,
hot flashes) and vaginal symptoms such as vaginal dryness and pain with
intercourse are 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.
Important Information About Estrogens
Cardiovascular and other Risks
Estrogens with or without progestins should not be used for the
prevention of cardiovascular disease or dementia.
The estrogen alone substudy of Women's Health Initiative (WHI) study
reported increased risks of stroke and deep vein thrombosis in
postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1
years, respectively, of treatment with oral conjugated estrogens (CE 0.625
mg) relative to placebo.
The estrogen-plus-progestin substudy of the WHI reported increased
risks of myocardial infarction, stroke, invasive breast cancer, pulmonary
emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of
age) during 5.6 years of treatment with oral CE 0.625 mg combined with
medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. The
Women's Health Initiative Memory Study (WHIMS), a substudy of WHI study,
reported increased risk of developing probable dementia in postmenopausal
women 65 years of age or older during 5.2 years of treatment with CE 0.625
mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA
2.5 mg, relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women.
Other doses of oral conjugated estrogens with medroxyprogesterone
acetate, and other combinations and dosage forms of estrogens and
progestins were not studied in the WHI clinical trials and, in the absence
of comparable data, these risks should be assumed to be similar. Because of
these risks, estrogens with or without progestins should be prescribed at
the lowest effective doses and for the shortest duration consistent with
treatment goals and risks for the individual woman.
About ENJUVIA
ENJUVIA tablets are indicated for: the treatment of moderate-to-severe
vasomotor symptoms associated with menopause; and treatment of moderate to
severe vaginal dryness and pain with intercourse, symptoms of vulvar and
vaginal atrophy, associated with menopause. When prescribing solely for the
treatment of moderate to severe vaginal dryness and pain with intercourse,
topical vaginal products should be considered.
Patients should be started at the lowest approved dose of 0.3 mg
ENJUVIA daily. Subsequent dosage adjustment may be made based upon the
individual patient response. This dose should be periodically reassessed by
the healthcare provider.
The most common side effects in the clinical trials were headache,
pain, nausea, and breast pain. In clinical trials, adverse events that
occurred at a rate greater than or equal to 5% and greater than placebo,
regardless of relationship to study drug, included: abdominal pain,
accidental injury, breast pain, bronchitis, dizziness, dysmenorrhea,
flatulence, flu syndrome, headache, nausea, pain, paresthesia, rhinitis,
sinusitis, and vaginitis.
ENJUVIA tablets should not be used in individuals with any of the
following conditions: undiagnosed abnormal genital bleeding; known,
suspected, or history of cancer of the breast; known or suspected
estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary
embolism or a history of these conditions; active or recent (e.g. within
the past year) arterial thromboembolic disease (e.g. stroke, myocardial
infarction); liver dysfunction or disease; hypersensitivity to its
ingredients; or known or suspected pregnancy. There is no indication for
ENJUVIA in pregnancy. There appears to be little or no increased risk of
birth defects in children born to women who have used estrogens and
progestins from oral contraceptives inadvertently during early pregnancy.
Women and healthcare providers who would like to learn more about
ENJUVIA, including full prescribing information, should visit
http://www.ENJUVIA.com.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 115 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements can be
identified by their use of words such as "expects," "plans," "projects,"
"will," "may," "anticipates," "believes," "should," "intends," "estimates"
and other words of similar meaning. Because such statements inherently
involve risks and uncertainties that cannot be predicted or quantified,
actual results may differ materially from those expressed or implied by
such forward-looking statements depending upon a number of factors
affecting the Company's business. These factors include, among others: the
difficulty in predicting the timing and outcome of legal proceedings,
including patent-related matters such as patent challenge settlements and
patent infringement cases; the outcome of litigation arising from
challenging the validity or non- infringement of patents covering our
products; the difficulty of predicting the timing of FDA approvals; court
and FDA decisions on exclusivity periods; the ability of competitors to
extend exclusivity periods for their products; our ability to complete
product development activities in the timeframes and for the costs we
expect; market and customer acceptance and demand for our pharmaceutical
products; our dependence on revenues from significant customers;
reimbursement policies of third party payors; our dependence on revenues
from significant products; the use of estimates in the preparation of our
financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to
launch new products in the timeframes we expect; the availability of raw
materials; the availability of any product we purchase and sell as a
distributor; the regulatory environment in the markets where we operate;
our exposure to product liability and other lawsuits and contingencies; the
increasing cost of insurance and the availability of product liability
insurance coverage; our timely and successful completion of strategic
initiatives, including integrating companies (such as PLIVA d.d.) and
products we acquire and implementing our new SAP enterprise resource
planning system; fluctuations in operating results, including the effects
on such results from spending for research and development, sales and
marketing activities and patent challenge activities; the inherent
uncertainty associated with financial projections; our expansion into
international markets through our PLIVA acquisition, and the resulting
currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly
increased debt obligations as a result of the PLIVA acquisition; changes in
generally accepted accounting principles; and other risks detailed in our
SEC filings, including in our Transition Report on Form 10-K/T for the six
months ended December 31, 2006.
The forward-looking statements contained in this press release speak
only as of the date the statement was made. The Company undertakes no
obligation (nor does it intend) to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise, except to the extent required under applicable law.
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com/
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CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com; or Dave Schemelia of
HealthSTAR Public Relations, +1-212-532-0909,
dschemelia@healthstarpr.com
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