TherapeuticsMD Announces Publication of Two Manuscripts on the Rejoice Trial for TX-004HR in Leading Peer-Reviewed Medical Journal
– Positive results from pivotal, phase 3 Rejoice Trial published for
first time in the journal Menopause –
BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced the publication of two manuscripts detailing
results of the company’s phase 3 Rejoice Trial in Menopause: The
Journal of The North American Menopause Society, a widely-regarded
forum for scholarly articles on the leading research related to
menopause. The Rejoice Trial is the pivotal phase 3 study of TX-004HR,
an investigational bio-identical 17β-estradiol vaginal softgel capsule,
for the treatment of moderate-to-severe vaginal pain during sexual
intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in
postmenopausal women.
The manuscripts review the positive results of TX-004HR across all
pre-specified primary and secondary endpoints in the Rejoice Trial, as
well as data from a pharmacokinetic (PK) substudy demonstrating the low
systemic absorption of TX-004HR. Both manuscripts are available online
in the journal Menopause, as well as in the “Investors & Media” section
of the company’s website, www.therapeuticsmd.com.
“Publication of our two manuscripts on the Rejoice Trial is an important
achievement for our company, reflecting the clinical rigor that guides
development of our unique pipeline of hormone therapies designed to
address women’s healthcare needs,” said TherapeuticsMD CEO Robert G.
Finizio. “If approved, TX-004HR has the potential to be a highly
differentiated treatment option for postmenopausal women in the United
States who suffer from moderate-to-severe dyspareunia, a symptom of VVA.
We look forward to the Food and Drug Administration completing its
review of the TX-004HR New Drug Application (NDA), and to the potential
launch of TX-004HR in 2017.”
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action
date of May 7, 2017 to complete its review of the company’s 505(b)(2)
NDA submission for TX-004HR. The NDA is supported by the complete
TX-004HR clinical program, including positive results of the phase 3
Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4
mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.
The first manuscript, titled “The REJOICE trial: a phase 3 randomized,
controlled trial evaluating the safety and efficacy of a novel vaginal
estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy,”
reviews the results of the Rejoice Trial, which demonstrated
statistically significant improvements in dyspareunia, based on four
co-primary endpoints, and vaginal dryness, a secondary endpoint, across
all three doses of TX-004HR compared to placebo. The manuscript also
reviews the safety and tolerability of TX-004HR. TX-004HR had a
favorable safety profile and was well-tolerated. No clinically
significant differences in adverse events were observed between
treatment and placebo groups.
The second manuscript, titled “TX-004HR vaginal estradiol has negligible
to very low systemic absorption of estradiol,” reviews the results of
the PK substudy of the Rejoice Trial, which demonstrated that all three
doses of TX-004HR showed negligible to very low systemic absorption of
estradiol. Safety parameters further revealed no significant differences
in estrogen sensitive tests and no signals of estrogenic stimulation of
the endometrium.
“We are very encouraged by the safety and efficacy profile of TX-004HR
and, if approved, believe this product candidate could become a
potential best in class therapy for postmenopausal women seeking to
effectively manage dyspareunia, a symptom of VVA,” said TherapeuticsMD
Chief Clinical Officer Brian Bernick, M.D.
About Vulvar and Vaginal Atrophy (VVA)
An estimated 32 million women in the United States are currently
suffering from symptoms of VVA, and only 2.3 million (7 percent) are
currently being treated with prescription therapy. VVA symptoms can
range from mild to severe and include dyspareunia, vaginal dryness,
urinary tract infections, and vaginal bleeding associated with sexual
activity. Vaginal dryness and dyspareunia are considered the most
bothersome symptoms of VVA. Because of the chronic nature of VVA due to
menopause, its symptoms will not likely resolve without intervention.
The burden of VVA in the United States may increase due to aging of the
population. 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.
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 as well as over-the-counter 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
Media
Contact
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com
