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TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXY (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, Due to Menopause

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-IMVEXXY's applicator-free self-administration was developed with the
woman in mind-

-TherapeuticsMD will host a conference call at 8:00 AM EDT today-

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare
company, today announced that the United States Food and Drug
Administration (FDA) has approved IMVEXXY (estradiol vaginal inserts)
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
representing the lowest approved dose of vaginal estradiol available.

"IMVEXXY is a bio-identical vaginal estrogen product that offers a
fraction of the estrogen contained in the average doses of many existing
products currently on the market," said Brian Bernick, MD, Chief
Clinical Officer of TherapeuticsMD. "IMVEXXY is the only product
specifically designed to be applicator-free. It dissolves completely
without mess or additional clean-up, and can be used anytime of day. It
allows women the freedom to immediately return to their normal daily
activities. Studies showed that, in patients who used IMVEXXY, systemic
absorption of estradiol remained within postmenopausal range."

"We are excited to bring IMVEXXY to market as TherapeuticsMD's first
FDA-approved drug as we strive to be the premier Women's Health
Company," said Robert Finizio, Chief Executive Officer of
TherapeuticsMD. "IMVEXXY reflects our long-standing corporate mission
and commitment to health solutions that women want, based on the
concepts of medical need, efficacy, safety, simplicity, and
affordability. IMVEXXY will be offered at a price in parity with other
products that have been on the market for 10 to 30 years. By ensuring
patients can access IMVEXXY at an affordable price, TherapeuticsMD is
doing the right thing for women."

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.2

VVA affects an estimated 32 million postmenopausal women in the US. Only
about seven percent (2.3 million) of these women receive prescription
treatment.3 Nearly 1 out of 2 women will experience pain
during intercourse due to VVA at some point during their lives.3

"Studies have shown that many women are not seeking treatment for VVA
and 81% are unaware that VVA is a treatable medical condition and part
of a constellation of symptoms associated with loss of estrogens," said
Dr. Sheryl Kingsberg, President, North American Menopause Society. "I am
delighted that our patients will now have a convenient treatment option
with IMVEXXY and hope that the excitement generated by this new option
will encourage women to talk to their healthcare provider and get relief
from their pain and discomfort due to VVA."

IMVEXXY For the Treatment of Moderate to Severe Dyspareunia Due to
Menopause

Imvexxy's mechanism of action is the re-estrogenization of the tissue in
and around the vagina. IMVEXXY's distinctive formulation ensures that it
dissolves completely without mess, so patients can use it any time of
day by placing the softgel capsule in the lower part of the vagina to
treat the vulva and vagina. IMVEXXY is administered daily for two weeks
followed by only twice a week dosing. Nine out of 10 patients who
participated in a clinical trial reported that IMVEXXY was "easy to use."4

The FDA approval of IMVEXXY is based on the results of a Phase 3,
randomized, double-blind, placebo-controlled study that evaluated the
safety and efficacy of IMVEXXY (4 mcg and 10 mcg) compared to placebo
from baseline to week 12. The study showed that IMVEXXY provided relief
of moderate to severe dyspareunia due to menopause as early as week 2
for both doses.5 Statistically significant changes in vaginal
cytology and pH were also observed.5 A substudy of the
REJOICE trial evaluated the pharmacokinetics of IMVEXXY 4 mcg, 10 mcg,
and placebo. With both the 4 mcg and 10 mcg doses, the mean
concentration of estradiol and estrone remained within average
postmenopausal range.6 The results were published in the
journal Menopause: The Journal of The North American Menopause Society.5,6

The most common adverse reaction with IMVEXXY (incidence ≥3 percent) and
greater than placebo was headache. There were no clinically significant
differences in AEs observed between treatment and placebo groups.5
Important safety information for IMVEXXY, including the boxed warning
for endometrial cancer, cardiovascular disorders, breast cancer, and
probable dementia, is provided below. The full prescribing information
may be viewed by visiting www.imvexxy.com.

TherapeuticsMD anticipates that IMVEXXY will be available for commercial
distribution in July.

As part of the FDA's approval, TherapeuticsMD has committed to conduct a
post-approval observational study.

Conference Call Information

TherapeuticsMD will host a conference call today to discuss the IMVEXXY
approval. Details for the call are:

Date:       Wednesday, May 30, 2018
Time: 8:00 AM EDT
Telephone Access (US): (866) 665-9531
Telephone Access (International): (724) 987-6977
Access Code for All Callers: 4757309

Additionally, a live webcast can be accessed on the company's website, www.therapeuticsmd.com,
on the Home Page or under the "Investors & Media" section. A digital
recording of the conference call will be available for replay beginning
two hours after the call's completion and for at least 30 days with the
dial-in (855) 859-2056 or international (404) 537-3406 and Conference
ID: 4757309.

IMPORTANT SAFETY INFORMATION

 

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 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 has recently received FDA approval for TX-004HR, branded as
IMVEXXY™ (estradiol vaginal inserts), for the treatment of moderate to
severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to
menopause. The company's late stage clinical pipeline includes TX-001HR
for treatment of moderate-to-severe vasomotor symptoms (VMS) due to
menopause. The company also manufactures and distributes branded and
generic prescription prenatal vitamins as well as over-the-counter
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: 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 its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company 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; 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.

References:

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. Wysocki S, Kingsberg S, Krychman M. Management of vaginal atrophy:
implications from the REVIVE survey. Clin Med Insights Reprod Health.
2014;8:23-30.

4. Kingsberg SA, Kroll R, Goldstein I, et al. Patient acceptability and
satisfaction with a low-dose solubilized vaginal estradiol softgel
capsule, TX-004HR. Menopause. 2017;24:894-899.

5. Constantine GD, Simon JA, Pickar JH, et al. The REJOICE trial: a
phase 3 randomized, controlled trial evaluating the safety and efficacy
of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and
vaginal atrophy. Menopause. 2017;24:409-416.

6. Archer DF, Constantine GD, Simon J, et al.TX-004HR Vaginal Estradiol
Has Negligible to Very Low Systemic Absorption of Estradiol. Menopause
2017;24:510-516.

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