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Press Release

TherapeuticsMD Announces Multiple Presentations Related to TX-004HR and TX-001HR at NAMS 2017

TherapeuticsMD,Inc.
Posted on: 05 Oct 17

TherapeuticsMD, Inc. (NYSE American:TXMD), an innovative women’s healthcare company, today announced the schedule of nine presentations at NAMS 2017, the annual meeting of the North American Menopause Society, in Philadelphia, Pennsylvania, October 11-14, related to TX-004HR, the company’s investigational applicator-free vaginal estradiol softgel capsule in development for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause, and TX-001HR, the company’s 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.

Five oral presentations reviewing the detailed findings of the pivotal Phase 3 Replenish Trial will provide new data supporting the overall safety and efficacy of TX-001HR. These data will include additional MENQOL (quality of life) scores, uterine bleeding rates, and sleep outcomes.

“We are pleased to present additional new data from the Replenish Trial at the annual meeting of the North American Menopause Society, further supporting the safety and efficacy of TX-001HR as the first bio-identical combination hormone therapy of estradiol and progesterone 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.”

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

TX-004HR Oral Presentations and Posters

Title

  The WISDOM Survey: Physicians’ Behaviors and Attitudes towards Treating Vulvar and Vaginal Atrophy (VVA)

Date/Time

 

Thursday, October 12, 5:15 - 5:30 p.m. (Oral Presentation)

     
Title   The WISDOM Survey: Physicians’ Level of Comfort Prescribing Treatment for Vulvar and Vaginal Atrophy (VVA) Symptoms in Women with a Predisposition or History of Breast Cancer

Date/Time

 

Thursday, October 12, 5:30 - 5:45 p.m. (Oral Presentation)

     
Title   REJOICE Trial: TX-004HR Consistently Improved Vaginal Dryness in Subgroups of Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) and Dyspareunia

Date/Time

 

Thursday, October 12, 6:00 - 7:00 p.m. (Poster Presentation)

     
Title   TX-004HR Improved Moderate-to-Severe Dyspareunia and Vaginal Dryness Associated with Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Date/Time

 

Thursday, October 12, 6:00 - 7:00 p.m. (Poster Presentation)

 

TX-001HR Oral Presentations

Title

  TX-001HR is Associated with a Clinically Meaningful Effect on Vasomotor Symptoms

Date/Time

 

Friday, October 13, 1:00 – 1:15 p.m. (Oral Presentation)

     

Title

  17β-Estradiol/Progesterone in a Single Oral Softgel Capsule (TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor Symptoms without Endometrial Hyperplasia

Date/Time

 

Friday, October 13, 4:30 – 4:45 p.m. (Oral Presentation)

     

Title

  TX-001HR Improved the Medical Outcomes Study-Sleep (MOS-Sleep) Questionnaire in Menopausal Women with Vasomotor Symptoms

Date/Time

 

Friday, October 13, 4:45 – 5:00 p.m. (Oral Presentation)

     

Title

  Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms

Date/Time

 

Friday, October 13, 5:00 – 5:15 p.m. (Oral Presentation)

     

Title

  TX-001HR Improved Quality of Life in Menopausal Women with Vasomotor Symptoms

Date/Time

 

Friday, October 13, 5:15 – 5:30 p.m. (Oral Presentation)

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 resolve the deficiencies identified by the FDA in the company’s new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the company will be able to prepare an amended NDA for its TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; 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 an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the length, cost and uncertain results of the company’s clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; 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 .

View source version on businesswire.com: http://www.businesswire.com/news/home/20171005005063/en/

Business Wire
www.businesswire.com

Last updated on: 05/10/2017

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