No significant difference in the risk of invasive breast cancer,
stroke, colorectal cancer, endometrial cancer, and venous
thromboembolism in vaginal estrogen users vs nonusers
Lower risk of cardiovascular disease, hip fracture, and all-cause
mortality in vaginal estrogen users with an intact uterus vs nonusers
with an intact uterus
BOCA RATON, Fla.--(BUSINESS WIRE)--Aug. 16, 2017--
TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare
company, today announced the publication of the manuscript detailing
results of the Women’s Health Initiative Observational Study of vaginal
estrogen use in postmenopausal women in Menopause: The Journal of The
North American Menopause Society, a widely-regarded forum for
scholarly articles on the leading research related to menopause. The
Women’s Health Initiative Observational Study, conducted from 1993 to
2005, is an NIH-sponsored, observational study that enlisted 93,676
postmenopausal women between the ages of 50 to 79 to give reliable
estimates of the extent to which known risk factors predict heart
disease, cancers, and fractures.
The manuscript, titled “Breast cancer, endometrial cancer, and
cardiovascular events in participants who used vaginal estrogen in the
Women’s Health Initiative Observational Study,” represents the first,
large prospective observational study that evaluates the overall health
risks and benefits of vaginal estrogen therapy. The study demonstrated
no significant difference in the risk of invasive breast cancer, stroke,
colorectal cancer, endometrial cancer, and venous thromboembolism in
vaginal estrogen users vs nonusers. The study also shows that, among
women with an intact uterus, there was a decreased risk of
cardiovascular disease, hip fracture, and all-cause mortality in vaginal
estrogen users vs nonusers. The study evaluated over 4,000 women who
used vaginal estrogens for a median duration of two to three years. The
manuscript is available online in the journal Menopause.
“This is the first study identifying the real world use of vaginal
estrogen and the associated risks and benefits. We believe that these
data, which includes two to three years of median duration of use of
vaginal estrogen products, should address the only approvability issue
raised by the FDA for TX-004HR – the lack of long-term endometrial
safety data beyond the 12 weeks studied in the REJOICE trial,” said
TherapeuticsMD Chief Medical Officer Sebastian Mirkin.
TherapeuticsMD intends to submit the manuscript to the New Drug
Application (NDA) for TX-004HR, the company’s investigational
applicator-free estradiol vaginal softgel capsule for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause, as part
of the Company’s submission of additional endometrial safety information
to the FDA on or before September 18, 2017.
“The recently published article in Menopause on vaginal estrogen
and clinical outcomes, including cardiovascular disease and cancer, in
the Women’s Health Initiative Observational Study demonstrates no
elevation in risk of these adverse outcomes among postmenopausal women
using vaginal estrogen, providing further reassurance about the safety
of treatment,” said JoAnn Manson, MD, Professor of Medicine at Harvard
Medical School and Brigham and Women’s Hospital, past President of the
North American Menopause Society, and coauthor of the new study
published in Menopause. “This study adds to the totality of the
scientific evidence that supports a distinction between low-dose vaginal
and systemic estrogen products, including modifications in the labeling
of low-dose vaginal estrogen products.”
About Vulvar and Vaginal Atrophy (VVA)
An estimated 32 million women in the United States are currently
suffering from symptoms of VVA, and only 2.3 million (7 percent) are
currently being treated with prescription therapy. VVA symptoms can
range from mild to severe and include dyspareunia, vaginal dryness,
urinary tract infections, and vaginal bleeding associated with sexual
activity. Vaginal dryness and dyspareunia are considered the most
bothersome symptoms of VVA. Because of the chronic nature of VVA due to
menopause, its symptoms will not likely resolve without intervention.
The burden of VVA in the United States may increase due to aging of the
population. Furthermore, due to increasing longevity, women may now
suffer from VVA or other conditions related to decreased reproductive
hormone levels for over one-third of their lives.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing products exclusively for women. With its
SYMBODA™ technology, TherapeuticsMD is developing advanced hormone
therapy pharmaceutical products to enable delivery of bio-identical
hormones through a variety of dosage forms and administration routes.
The company’s late stage clinical pipeline includes two phase 3 product
candidates: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The
company also manufactures and distributes branded and generic
prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD®
brands.
Forward-Looking Statements
This press release by TherapeuticsMD, Inc. may contain forward-looking
statements. Forward-looking statements may include, but are not limited
to, statements relating to TherapeuticsMD’s objectives, plans and
strategies as well as statements, other than historical facts, that
address activities, events or developments that the company intends,
expects, projects, believes or anticipates will or may occur in the
future. These statements are often characterized by terminology such as
“believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,”
“will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and
similar expressions and are based on assumptions and assessments made in
light of management’s experience and perception of historical trends,
current conditions, expected future developments and other factors
believed to be appropriate. Forward-looking statements in this press
release are made as of the date of this press release, and the company
undertakes no duty to update or revise any such statements, whether as a
result of new information, future events or otherwise. Forward-looking
statements are not guarantees of future performance and are subject to
risks and uncertainties, many of which are outside of the company’s
control. Important factors that could cause actual results, developments
and business decisions to differ materially from forward-looking
statements are described in the sections titled “Risk Factors” in the
company’s filings with the Securities and Exchange Commission, including
its most recent Annual Report on Form 10-K and Quarterly Reports on Form
10-Q, as well as reports on Form 8-K, and include the following: the
company’s ability to resolve the deficiencies identified by the FDA in
the company’s new drug application for its TX-004HR product candidate
and the time frame associated with such resolution; whether the company
will be able to prepare an amended NDA for its TX-004HR product
candidate and, if prepared, whether the FDA will accept and approve the
NDA; the company’s ability to maintain or increase sales of its
products; the company’s ability to develop and commercialize its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company will be able to prepare an NDA for its
TX-001HR product candidate and, if prepared, whether the FDA will accept
and approve the NDA; the length, cost and uncertain results of the
company’s clinical trials, including any additional clinical trials that
the FDA may require in connection with TX-004HR; the potential of
adverse side effects or other safety risks that could preclude the
approval of the company’s hormone therapy drug candidates; the company’s
reliance on third parties to conduct its clinical trials, research and
development and manufacturing; the availability of reimbursement from
government authorities and health insurance companies for the company’s
products; the impact of product liability lawsuits; the influence of
extensive and costly government regulation; the volatility of the
trading price of the company’s common stock and the concentration of
power in its stock ownership. PDF copies of the company’s historical
press releases and financial tables can be viewed and downloaded at its
website: www.therapeuticsmd.com/pressreleases.aspx.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170816006050/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact
David DeLucia,
561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com