TherapeuticsMD Announces Multiple Presentations Related to Imvexxy™ and TX-001HR at the 2018 Annual Meeting of the North American Menopause Society

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare
company, today announced the schedule of ten oral presentations and
posters at NAMS 2018, the annual meeting of the North American Menopause
Society being held in San Diego, California on October 3-6, 2018,
related to ImvexxyTM (estradiol vaginal inserts) and
TX-001HR, the Company’s investigational bio-identical hormone therapy
combination of estradiol and progesterone in a single, oral softgel for
the treatment of moderate-to-severe vasomotor symptoms due to menopause.

There will be three oral presentations reviewing the findings of the
Phase 3 Replenish Trial of TX-001HR and the systemic profile of Imvexxy
(TX-004HR).

“We are pleased to present additional data from the Replenish Trial that
further support the safety and efficacy of TX-001HR as the first
bio-identical combination hormone therapy of estradiol and
progesterone,” said TherapeuticsMD Chief Medical Officer Sebastian
Mirkin, M.D. “The FDA PDUFA target action date for TX-001HR is October
28, 2018. If approved, TX-001HR would provide an FDA-approved treatment
option for the millions of postmenopausal women who are currently
seeking treatment for moderate to severe vasomotor symptoms using
unapproved compounded hormones.”

The posters and presentations will be made available on the Investors &
Media section of the company’s website at www.therapeuticsmd.com.

 

Oral Presentations

 
Date:         October 4, 2018
Time: 4:45-5:00 pm
Title:

Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on
Metabolic Parameters and Cardiovascular Outcomes in Menopausal
Women of the REPLENISH Trial

 
Date: October 5, 2018
Time: 4:15-4:30 pm
Title: 17β-Estradiol/Progesterone in a Single, Oral, Softgel Capsule
(TX-001HR) Significantly Increased the Number of Symptom-free Days
in the REPLENISH Trial
 
Date: October 5, 2018
Time: 5:00-5:15 pm
Title:

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel
Capsule (TX-004HR) in Menopausal Women with Moderate-to-Severe
Dyspareunia

 

Posters

Date: October 4, 2018
Time: 6:00-7:00 pm
 
Title: Physical Characteristics of TX-004HR: An Ultra-Low-Dose (4- and
10-µg) Estradiol Softgel Capsule Vaginal Insert
 
Title: A 17β-Estradiol, Softgel, Vaginal Capsule (TX-004HR) Demonstrated an
Early Onset of Action for Treating Vulvar and Vaginal Atrophy (VVA)
and Moderate-to-Severe Dyspareunia
 
Title: Systemic Estradiol Levels with Low-Dose Vaginal Estrogens May Differ
by Dose and by Product
 
Title: Correlations of Serum Estradiol and Estrone Concentrations with
Menopausal Outcomes and Bleeding
 
Title: Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on
Weight and Blood Pressure in Menopausal Women of the REPLENISH Trial
 
Title: Estradiol and Progesterone Bioavailability for Moderate-to-Severe
Vasomotor Symptom Treatment and Endometrial Protection with the
Continuous-Combined Regimen of TX-001HR (Oral Estradiol and
Micronized Progesterone Capsules)
 
Title: TX-001HR is Associated with a Clinically Meaningful Effect on
Severity of Moderate-to-Severe Vasomotor Symptoms in the REPLENISH
Trial
 

About Imvexxy

Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the
treatment of moderate-to-severe dyspareunia (vaginal pain associated
with sexual activity), a symptom of vulvar and vaginal atrophy (VVA),
due to menopause. Imvexxy is the only product in its therapeutic class
to offer a 4 mcg and 10 mcg dose, the 4 mcg dose representing the lowest
approved dose of vaginal estradiol available. The full prescribing
information may be viewed by visiting www.Imvexxy.com.

IMPORTANT SAFETY INFORMATION FOR IMVEXXY

 
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman
with a uterus who uses unopposed estrogens

• Estrogen-alone therapy should not be used for the prevention
of cardiovascular disease or dementia

• The Women’s Health Initiative (WHI) estrogen-alone substudy
reported increased risks of stroke and deep vein thrombosis (DVT)

• The WHI Memory Study (WHIMS) estrogen-alone ancillary study
of WHI reported an increased risk of probable dementia in
postmenopausal women 65 years of age and older

 

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular disease or dementia

• The WHI estrogen plus progestin substudy reported increased
risks of stroke, DVT, pulmonary embolism (PE) and myocardial
infarction (MI)

• The WHI estrogen plus progestin substudy reported increased
risks of invasive breast cancer

• The WHIMS estrogen plus progestin ancillary study of WHI
reported an increased risk of probable dementia in postmenopausal
women 65 years of age and older

 

CONTRAINDICATIONS

  • Imvexxy™ is contraindicated in women with any of the following
    conditions: undiagnosed abnormal genital bleeding; known, suspected,
    or history of breast cancer; known or suspected estrogen-dependent
    neoplasia; active DVT, PE, or history of these conditions; active
    arterial thromboembolic disease or a history of these conditions;
    known anaphylactic reaction or angioedema to Imvexxy; known liver
    impairment or disease; known protein C, protein S, or antithrombin
    deficiency, or other known thrombophilic disorders.

WARNINGS AND PRECAUTIONS

  • Imvexxy is intended only for vaginal administration. Systemic
    absorption may occur with the use of Imvexxy.
  • The use of estrogen-alone and estrogen plus progestin therapy has been
    reported to result in an increase in abnormal mammograms requiring
    further evaluation.
  • The WHI estrogen plus progestin substudy reported a statistically
    non-significant increased risk of ovarian cancer. A meta-analysis of
    17 prospective and 35 retrospective epidemiology studies found that
    women who used hormonal therapy for menopausal symptoms had an
    increased risk for ovarian cancer. The exact duration of hormone
    therapy use associated with an increased risk of ovarian cancer,
    however, is unknown.
  • Other warnings include: gallbladder disease; severe hypercalcemia,
    loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
  • Estrogen therapy may cause an exacerbation of asthma, diabetes
    mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus,
    and hepatic hemangiomas and should be used with caution in women with
    these conditions.
  • Women on thyroid replacement therapy should have their thyroid
    function monitored.

ADVERSE REACTIONS

  • The most common adverse reaction with Imvexxy (incidence ≥ 3 percent)
    and greater than placebo was headache.

Please note that this information is not comprehensive. Please visit www.Imvexxy.com
for the Full Prescribing Information, including the Boxed WARNING.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing novel products exclusively for women. Our
products are designed to address the unique changes and challenges women
experience through the various stages of their lives with a therapeutic
focus in family planning, reproductive health, and menopause management.
The company is committed to advancing the health of women and
championing awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit www.therapeuticsmd.com
or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

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: whether
the FDA will approve the NDA for the company’s TX-001HR product
candidate and whether such approval will occur by the PDUFA target
action date; the company’s ability to maintain or increase sales of its
products; the company’s ability to develop and commercialize IMVEXXYTM,
ANNOVERATM and its hormone therapy drug candidates and obtain
additional financing necessary therefor; whether the company will be
able to comply with the covenants and conditions under its term loan
agreement; the length, cost and uncertain results of the company’s
clinical trials; the potential of adverse side effects or other safety
risks that could preclude the approval of the company’s hormone therapy
drug candidates or adversely affect the commercialization of the
company’s current or future approved products; 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.

Contacts

TherapeuticsMD, Inc.
Investor Contact:
Nichol Ochsner,
561-961-1900, ext. 2088
Vice President Investor Relations
Nochsner@TherapeuticsMD.com