TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company
("TherapeuticsMD" or the "Company"), announced today that it received
approval to begin screening and enrolling subjects at its fiftieth site,
the University of Florida College of Medicine, in the Company’s
REPLENISH Trial, a phase 3, double-blind, placebo-controlled clinical
trial designed to measure the safety and effectiveness of TX 12-001HR,
the Company’s bio-identical combination 17ß-estradiol and progesterone
drug candidate, in treating the symptoms of menopause.
Robert G. Finizio, Chief Executive Officer and Co-founder, said, “I am
pleased to announce that we have achieved the fiftieth site enrollment
for this promising drug candidate within our target timeline of a little
more than three months from the start of patient enrollment in the
REPLENISH Trial. This is an important milestone for us in that we set
out to accomplish this goal before year-end, and we have in fact done
so. I applaud the hard work and perseverance that brought about this
significant achievement and look forward to making continued headway to
support our goal of bringing innovative women’s healthcare products to
market.”
About Hormone Therapy
Hormone therapy (HT) is the administration of hormones to supplement a
lack of naturally occurring hormones. HT options include natural,
bioidentical, and non-bioidentical (conjugated) hormones. HT is
projected to be the largest growth segment in the overall women’s health
market. In a recent study commissioned by the Company, inThought™, a
Symphony Health Solutions company, estimated the current market to be
over $3.7 billion per year.
Clinical endpoints of the REPLENISH Trial (www.ReplenishTrial.com)
include measuring the reduction in frequency and severity of hot flashes
over a 90-day period while ensuring endometrial protection for one year,
in accordance with FDA Guidance for Estrogen/Progestins.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on
developing and commercializing products targeted exclusively for women.
We are developing advanced hormone therapy pharmaceutical products based
on novel technologies that enable delivery of bioidentical hormones
through a variety of dosage forms and administration routes. We also
manufacture and distribute branded and generic prescription prenatal
vitamins, as well as over-the-counter vitamins and cosmetics, under our
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.
Except for the historical information contained herein, the matters
set forth in this press release, including statements regarding the
Company’s expectations with respect to the enrollment at the
fiftieth site of the Company’s REPLENISH Trial, the design of the
REPLENISH Trial, the Company’s belief that TX 12-001HR is a promising
drug candidate and that the approval of the fiftieth site in the
REPLENISH Trial is an important milestone, and the size and projected
growth of the HT market are forward-looking statements within the
meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially, including but not limited to: timely and successful
completion of clinical studies and the results thereof; challenges and
costs inherent in product marketing; the risks and uncertainties
associated with economic and market conditions; risks and uncertainties
associated with the Company’s business and finances in general; and
other risks detailed in the Company’s filings with the U.S. Securities
and Exchange Commission including its annual report on Form 10-K filed
on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such
filings. These forward-looking statements are based on current
information that may change. Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date of this press release. All forward-looking statements are qualified
in their entirety by this cautionary statement, and the Company
undertakes no obligation to revise or update any forward-looking
statement to reflect events or circumstances after the issuance of this
press release.
Copyright Business Wire 2014