Full Press Release Details
TherapeuticsMD, Inc. 8-K
Completes Enrollment in The Rejoice Trial,
a Phase 3 Clinical Trial of TX-004HR (estradiol in VagiCapTM)
Topline Results Expected in Fourth Quarter of 2015 -
RATON, Fla., June 9, 2015 - TherapeuticsMD Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today
announced that the Company has completed patient enrollment in The Rejoice Trial, a phase 3 clinical trial of TX-004HR (estradiol
in VagiCap ) to evaluate multiple doses of an investigational, applicator-free vaginal estradiol for the treatment of pain
during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
is an investigational bio-identical estradiol softgel capsule administered vaginally without the need for an applicator. The
Rejoice Trial is also collecting efficacy data on vaginal dryness, and vaginal and/or vulvar itching or burning.
studies have shown that current therapies used to treat VVA generate some concerns from women with respect to their efficacy,
convenience and safety," stated Sebastian Mirkin, MD., Chief Medical Officer of TherapeuticsMD. "TX-004HR was designed
to try to address these unmet needs. Completion of patient recruitment in the Rejoice Trial marks an important milestone in our
development efforts and we look forward to disclosing topline results from the Rejoice Trial later this year."
pivotal safety and efficacy study, the Rejoice Trial is a randomized, multicenter, double-blind, placebo-controlled study evaluating
three strengths of TX-004HR - 4 mcg, 10 mcg and 25 mcg. The 4 mcg strength represents a new low-dose option. The 12-week
trial enrolled over 700 participants in approximately 100 sites across the United States and Canada.
Vulvar and Vaginal Atrophy (VVA)
is a chronic condition resulting from the decrease in naturally occurring estrogen during menopause, resulting in thinning of
the vaginal lining and an increase in vaginal pH levels. Approximately half of postmenopausal women report having symptoms of
VVA.[1] In total, an estimated 32 million women in the United States are currently
suffering from symptoms of VVA[2], and only 2.3 million (7%) are currently being
treated with prescription therapy.1,[3] The burden of VVA in the United States
is likely to increase due to aging of the population.[4] Furthermore, due to
increasing longevity, women may now suffer from VVA or other conditions related to decreased reproductive hormone levels for over
one-third of their lives.4
TherapeuticsMD, Inc.
Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented
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
as well as over-the-counter vitamins under the vitaMedMD and BocaGreenMD brands. More information is available at the
following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy.
Mayo Clin Proc 2010;85:87-94
Kingsberg SA, Wysocki S, Magnus L, and Krychman ML. Vulvar
and vaginal atrophy in postmenopausal women: Findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal
Vaginal ChangEs) survey. J Sex Med 2013;10:1790-1799.
North American Menopause Society. The role of local vaginal
estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society.
Menopause 2007;14(3 Pt 1):355-69.
US Census Bureau. Age and Sex Composition: 2010. 2011 May.
Report No.: C2010BR-03.
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; 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.