TherapeuticsMD Presents Positive Phase 3 Data in Two Presentations for TX-001HR at ENDO 2017

- Results of the Replenish Trial show positive safety and efficacy of TX-001HR as the first potential bio-identical combination treatment for vasomotor symptoms in menopausal women -

BOCA RATON, Fla.--()--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced that data on TX-001HR, an 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, was presented at ENDO 2017, the annual meeting of the Endocrine Society in Orlando, Florida, April 1-4. The positive results of the pivotal phase 3 Replenish Trial data were featured in an oral and a poster presentation.

In the oral presentation today, Rogerio Lobo, M.D., professor of Obstetrics and Gynecology and Director of the Reproductive Endocrinology Program at Columbia University, reviewed the detailed findings from the Replenish Trial, the phase 3 study that evaluated the safety and efficacy of four doses of TX-001HR. The Replenish Trial demonstrated that two doses of TX-001HR (estradiol 1 mg/progesterone 100 mg and estradiol 0.5 mg/progesterone 100 mg) achieved a statistically significant and clinically meaningful reduction in both the frequency and severity of hot flashes compared to placebo at weeks 4 and 12, meeting all the co-primary efficacy endpoints.

Secondary endpoint data presented by Dr. Lobo also showed statistically significant improvement in both total and vasomotor menopause specific quality-of-life questionnaire (MENQOL) scores at week 12 and maintained through six and 12 months for these two doses of TX-001HR, further supporting the primary efficacy data shown in the Replenish Trial. MENQOL is a validated tool used to measure quality-of-life in postmenopausal women.

Dr. Lobo commented, “I am pleased to finally see evidence from a well-controlled trial supporting the use of defined doses of bio-identical estradiol and progesterone in combination to treat VMS. These study data, including both the primary and secondary endpoints, suggest that, if approved, TX-001HR will be a valuable new treatment option for women suffering from symptoms of menopause.”

Additionally, David Archer, M.D., professor of Obstetrics and Gynecology and Director of Clinical Research at the Jones Institute at Eastern Virginia Medical School, presented a poster that analyzed endometrial safety in the Replenish Trial. The data showed that TX-001HR resulted in no cases of endometrial hyperplasia or malignancy (0 percent) in all treatment groups, meeting the recommendations established by the U.S. Food and Drug Agency’s (FDA) draft guidance.

The most common adverse events in the Replenish Trial (>5 percent) reported on average in all the active treatment groups were headache, nasopharyngitis, breast tenderness, and upper respiratory infection. There were no unexpected safety signals.

“TX-001HR is the first bio-identical combination hormone therapy of estradiol and progesterone to demonstrate safety and efficacy data 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.”

Both the oral and poster presentations from ENDO 2017 are available in the “Investors & Media” section of the company’s website at www.therapeuticsmd.com.

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 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 its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; 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.

Contacts

TherapeuticsMD, Inc.
Investor Contact
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
SparkBioComm
Media Contact
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com

Release Summary

REPLENISH trial shows that, if approved, TherapeuticsMD's TX-001HR will be a valuable new treatment option for women suffering from symptoms of menopause.

Contacts

TherapeuticsMD, Inc.
Investor Contact
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
SparkBioComm
Media Contact
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com