Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Provides TX-004HR Regulatory
BOCA RATON, Fla. - July
17, 2017 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced a regulatory
update regarding the New Drug Application (NDA) for TX-004HR, the company's investigational applicator-free estradiol vaginal
softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar
and vaginal atrophy (VVA) due to menopause.
On June 14, 2017, the Company participated
in a Type A Post-Action Meeting with the Division of Bone, Reproductive, and Urologic Products (DBRUP) of the Food and Drug Administration
(FDA) to discuss the Complete Response Letter (CRL) that the Company previously received for the NDA for TX-004HR. The meeting
enabled the Company to present new information that the Company believes could address concerns raised by the FDA in the CRL and
positively affect the status of the NDA for TX-004HR.
The Company has received the minutes of
the meeting and, per the FDA's request, has formally submitted the new information for consideration related to the NDA for
The Company continues to have a productive
dialogue with the FDA related to its review of this information but has not yet received a formal timeline from the FDA for a conclusion
of such review. The Company expects to have additional clarity on the pathway forward for the NDA for TX-004HR in the coming weeks.
The Company looks forward to working with the FDA to address its concerns regarding the NDA for TX-004HR and reserves the right
to pursue the FDA's formal dispute resolution process if a reasonable timeline to address such concerns cannot be established.
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
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.
Director, Investor Relations