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TherapeuticsMD Announces Commercial Availability of Imvexxy™ 4 mcg

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Imvexxy 4 mcg dose now commercially available in the United States

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare
company, today announced the commercial availability of Imvexxy™
(estradiol vaginal inserts) 4 mcg dose in the United States. Imvexxy 4
mcg is the lowest dose vaginal estrogen product approved by the U.S.
Food and Drug Administration (FDA) for 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 representing the lowest approved dose of vaginal estradiol available.

"We are incredibly excited to launch the 4 mcg dose of Imvexxy, which is
the lowest dose vaginal estradiol product approved by the FDA, and which
follows the 10 mcg dose that became commercially available early in
August," said Robert Finizio, Chief Executive Officer of TherapeuticsMD.
"These two distinct doses meet the different needs of women and their
healthcare providers. Imvexxy was designed with clinical and physical
attributes to help provide a positive user experience. Imvexxy is
administered as a softgel vaginal insert that dissolves completely
within hours, so patients can use it any time of day."

For postmenopausal women with VVA, Imvexxy provides improvement in
moderate-to-severe dyspareunia within 12 weeks, and beginning as early
as two weeks for some women, which was a secondary endpoint in the
pivotal Phase 3 clinical trial of Imvexxy. In general, women should
begin treatment at the 4 mcg dose, and may consider the 10 mcg dose
depending on their clinical response. Imvexxy is inserted about two
inches into the vagina to re-estrogenize the tissue in and around the
vagina. Imvexxy is administered daily for two weeks followed by only
twice a week dosing to maintain treatment.

About Dyspareunia and Vulvar and Vaginal Atrophy (VVA)

VVA is a component of genitourinary syndrome of menopause (GSM), which
may include, but is not limited to, genital symptoms of dryness, burning
and irritation, sexual symptoms such as decreased lubrication,
discomfort, and pain, and urinary symptoms such as urgency, dysuria, and
recurrent urinary tract infections.1 VVA is a chronic,
progressive condition that leads to distressing symptoms and can
progressively worsen if not treated.2

VVA is a condition that develops when the body makes less estrogen due
to menopause. Without sufficient estrogen, the vaginal tissue becomes
thin, dry, and less elastic. The vaginal canal can also narrow and
shorten. Insufficient estrogen can also decrease vaginal fluids, change
the acid balance of the vagina, and weaken pelvic floor muscles. All
these factors can lead to dyspareunia.3

VVA affects an estimated 32 million postmenopausal women in the US.4
Only about seven percent (2.3 million) of these women receive
prescription treatment. Nearly one out of two women will experience pain
during intercourse due to VVA at some point during their postmenopausal
years.5

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 IMVEXXY™,
ANNOVERA 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.

1 Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology
Consensus Conference Panel. Genitourinary syndrome of menopause: new
terminology for vulvovaginal atrophy from the International Society for
the Study of Women's Sexual Health and the North American Menopause
Society. Menopause. 2014;21(10):1063-1068.

2 The North American Menopause Society. Management of
symptomatic vulvovaginal atrophy: 2013 position statement of The North
American Menopause Society. Menopause. 2013;20(9):888–902.

3 The North American Menopause Society. Management of
symptomatic vulvovaginal atrophy: 2013 position statement of The North
American Menopause Society. Menopause. 2013;20(9):888–902.

4 Wysocki S, Kingsberg S, Krychman M. Management of vaginal
atrophy: Implications from the REVIVE Survey. Clin Med Insights Reprod
Health. 2014;8:23‐30. Kingsberg SA, Krychman M, Graham S, Bernick B,
Mirkin S. The Women's EMPOWER Survey: Identifying women's perceptions on
vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14:413‐424.

5 Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S.
The Women's EMPOWER Survey: Identifying women's perceptions on vulvar
and vaginal atrophy and its treatment. J Sex Med. 2017;14:413‐424.

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