TherapeuticsMD Announces Positive Top-Line Results from Pivotal Phase 3 Replenish Trial in Postmenopausal Women with Moderate to Severe Vasomotor Symptoms (VMS) Treated with TX-001HR - TX-001HR, the

TherapeuticsMD, Inc. 8-K

Announces Positive Top-Line Results from Pivotal Phase 3 Replenish Trial in Postmenopausal Women with Moderate to Severe Vasomotor

Symptoms (VMS) Treated with TX-001HR

TX-001HR, the first bio-identical combination therapy of estradiol and progesterone evaluated in a randomized, controlled clinical

trial met all co-primary efficacy and safety endpoints at multiple doses -

TX-001HR, if approved, offers a potential new alternative for millions of post-menopausal women currently using unapproved compounded

hormone therapy for the treatment of VMS -

Conference call today at 4:30 p.m. ET to discuss results -

RATON, Florida, December 5, 2016 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company,

today announced positive top-line results from its pivotal phase 3 Replenish Trial of TX-001HR, an investigational bio-identical

hormone therapy combination of 17 -estradiol and progesterone in a single, oral softgel, for the treatment of moderate to

severe vasomotor symptoms (VMS) due to menopause in post-menopausal women with an intact uterus.

Replenish Trial evaluated four doses of TX-001HR and placebo in 1,835 post-menopausal women between 40 and 65 years old. The doses

17 -estradiol 1 mg/progesterone 100 mg (n = 416)

17 -estradiol 0.5 mg/progesterone 100 mg (n = 423)

17 -estradiol 0.5 mg/progesterone 50 mg (n = 421)

17 -estradiol 0.25 mg/progesterone 50 mg (n = 424)

Replenish Trial results demonstrated:

outlined in the FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number

and severity of hot flashes at weeks 4 and 12 as compared to placebo.1

The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment. General safety

results of the Replenish Trial are summarized in the table below (p-values of < 0.05 meet FDA guidance and support evidence

are very pleased that multiple doses of TX-001HR studied in the Replenish Trial demonstrated these positive results, suggesting

that, if approved, this drug product candidate is poised to address the significant demand for bio-identical hormone therapy,"

said Chief Executive Officer Robert G. Finizio. "We have successfully advanced the science for post-menopausal women's

health by finding a way to effectively combine bio-identical estradiol and bio-identical progesterone. The need for a bio-identical

FDA-approved combination therapy has been unanswered for decades, driving women to use unapproved drugs mixed together by independent

and community pharmacies that compound these products. We believe that TX-001HR, if approved, will provide women, healthcare

providers and pharmacists with a proven safe, effective and insurance reimbursed bio-identical combination product, finally answering

that need. We will continue to evaluate these promising data, and look forward to submitting a New Drug Application

for TX-001HR to the Food and Drug Administration as early as the third quarter of 2017."

trial also demonstrated a dose response favoring the higher doses of estradiol in combination with progesterone. The availability

of multiple doses of TX-001HR would allow for individualized therapy to meet the needs of a diverse population of women.

most common adverse events (>5 percent) reported on average in all the active treatment groups were headache, nasopharyngitis,

breast tenderness, and upper respiratory infection. There was a very low reported incidence of adverse events of somnolence with

TX-001HR, in contrast to commercially available oral progesterone where somnolence has been reported as a significant side effect.

There were no unexpected safety signals.

Replenish Trial evaluated various secondary endpoints using well-validated patient reported outcome tools, including the Menopause-Specific

Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder analysis rate. Both TX-001HR estradiol

1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg demonstrated clinically meaningful and statistically

significant improvements in the secondary endpoints using these tools.

efficacy and safety analyses of the Replenish Trial data are ongoing and TherapeuticsMD plans to submit the full Replenish Trial

results for presentation at future scientific meetings and for publication in peer-reviewed journals.

is the first bio-identical combination hormone therapy of estradiol in combination with progesterone to be evaluated in a large,

well-controlled, randomized clinical trial," said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. "The

Replenish Trial demonstrated for the first-time safety and robust efficacy for the treatment of hot flashes at multiple doses

of TX-001HR. If approved, TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg would

provide TherapeuticsMD with a complete portfolio to meet the demands of women currently taking

unapproved compounded hormones for the treatment of VMS, along with the healthcare providers and pharmacies that prescribe and

compound these products."

is a novel combination of 17 -estradiol and natural progesterone under investigation for treating vasomotor symptoms related

to menopause. If approved by the FDA, TX-001HR would represent the first bio-identical estradiol and progesterone approved for

use in a single, combined product for postmenopausal women with an intact uterus offering women an important alternative to both

the available FDA-approved synthetic (non-bio-identical) hormones and the unapproved compounded bio-identical hormone products.

Bio-identical refers to estradiol and progesterone that are molecularly identical to the hormones circulating naturally in the

woman's body. An estimated one to two-and-a-half million women in the U.S. are using unapproved, compounded bio-identical

hormone therapies to treat vasomotor symptoms.2 Leading medical societies and the FDA advise that compounded hormone

therapies may pose significant risk to women given lack of efficacy and safety data and lack of uniform manufacturing processes.

was developed using TherapeuticsMD's unique SYMBODATM technology (meaning "similar to the body"),

which enables partial and complete solubilization of estradiol and progesterone into medium-chain fatty acid oils often derived

Menopause and Vasomotor Symptoms (VMS)

is a natural life-stage transition for women with an average onset of 51 years. According to the United States Census Bureau,

approximately 43 million women in the U.S. are of menopausal age (45-64 years).3

the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) such as night

sweats, hot flashes, and sleep disturbances. VMS affect as many as 60-80 percent of all menopausal women.

women can benefit from hormone therapy (HT), also known as hormone replacement therapy (HRT), which is recognized by key medical

societies as the most effective treatment for relief of symptoms related to menopause.

will host a conference call today, during which management will discuss the top-line results of the pivotal phase 3 Replenish

Trial. Details for the call are:

Telephone Access (US): (866) 665-9531

Access (International): (724) 987-6977

Code for All Callers: 30215405

a live webcast of the conference call can be accessed on the company's website, www.therapeuticsmd.com, under the

"Investors & Media" section.

TherapeuticsMD, Inc.

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 clinical development pipeline includes

two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the

vitaMedMD and BocaGreenMD brands. More information is available at the following websites: www.therapeuticsmd.com,

www.vitamedmd.com and www.bocagreenmd.com.

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 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 a new drug application for its TX-001HR product candidate and, if prepared, whether

the FDA will accept and approve the application; whether the FDA will approve the company's new drug application for