Nine total presentations reviewing the detailed findings of the
complete TX-004HR and TX-001HR clinical programs
Five oral presentations reviewing the detailed findings of the
pivotal Phase 3 Replenish Trial of TX-001HR
BOCA RATON, Fla.--(BUSINESS WIRE)--Oct. 5, 2017--
TherapeuticsMD, Inc. (NYSE American:TXMD), an innovative women’s
healthcare company, today announced the schedule of nine presentations
at NAMS 2017, the annual meeting of the North American Menopause
Society, in Philadelphia, Pennsylvania, October 11-14, related to
TX-004HR, the company’s investigational applicator-free vaginal
estradiol softgel capsule in development for the treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA), due to menopause, and
TX-001HR, the company’s investigational bio-identical hormone therapy
combination of 17ß-estradiol and progesterone in a single, oral softgel,
for the treatment of moderate to severe vasomotor symptoms (VMS) due to
menopause.
Five oral presentations reviewing the detailed findings of the pivotal
Phase 3 Replenish Trial will provide new data supporting the overall
safety and efficacy of TX-001HR. These data will include additional
MENQOL (quality of life) scores, uterine bleeding rates, and sleep
outcomes.
“We are pleased to present additional new data from the Replenish Trial
at the annual meeting of the North American Menopause Society, further
supporting the safety and efficacy of TX-001HR as the first
bio-identical combination hormone therapy of estradiol and progesterone
in a large, well-controlled, randomized clinical trial,” said
TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “If
approved, TX-001HR would provide a validated new treatment option for
the millions of postmenopausal women who are currently taking unapproved
compounded hormones for the treatment of moderate to severe vasomotor
symptoms.”
The posters and presentations will be made available on the Investors &
Media section of the company’s website at www.therapeuticsmd.com.
Details include:
TX-004HR Oral Presentations and Posters
|
Title
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|
The WISDOM Survey: Physicians’ Behaviors and Attitudes towards
Treating Vulvar and Vaginal Atrophy (VVA)
|
Date/Time
|
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Thursday, October 12, 5:15 - 5:30 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
The WISDOM Survey: Physicians’ Level of Comfort Prescribing
Treatment for Vulvar and Vaginal Atrophy (VVA) Symptoms in Women
with a Predisposition or History of Breast Cancer
|
Date/Time
|
|
Thursday, October 12, 5:30 - 5:45 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
REJOICE Trial: TX-004HR Consistently Improved Vaginal Dryness in
Subgroups of Postmenopausal Women with Vulvar and Vaginal Atrophy
(VVA) and Dyspareunia
|
Date/Time
|
|
Thursday, October 12, 6:00 - 7:00 p.m. (Poster Presentation)
|
|
|
|
Title
|
|
TX-004HR Improved Moderate-to-Severe Dyspareunia and Vaginal
Dryness Associated with Vulvar and Vaginal Atrophy (VVA) in
Postmenopausal Women
|
Date/Time
|
|
Thursday, October 12, 6:00 - 7:00 p.m. (Poster Presentation)
|
|
TX-001HR Oral Presentations
|
Title
|
|
TX-001HR is Associated with a Clinically Meaningful Effect on
Vasomotor Symptoms
|
Date/Time
|
|
Friday, October 13, 1:00 – 1:15 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
17β-Estradiol/Progesterone in a Single Oral Softgel Capsule
(TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor
Symptoms without Endometrial Hyperplasia
|
Date/Time
|
|
Friday, October 13, 4:30 – 4:45 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
TX-001HR Improved the Medical Outcomes Study-Sleep (MOS-Sleep)
Questionnaire in Menopausal Women with Vasomotor Symptoms
|
Date/Time
|
|
Friday, October 13, 4:45 – 5:00 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women
with Vasomotor Symptoms
|
Date/Time
|
|
Friday, October 13, 5:00 – 5:15 p.m. (Oral Presentation)
|
|
|
|
Title
|
|
TX-001HR Improved Quality of Life in Menopausal Women with
Vasomotor Symptoms
|
Date/Time
|
|
Friday, October 13, 5:15 – 5:30 p.m. (Oral Presentation)
|
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/20171005005063/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact:
David DeLucia,
561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com