TherapeuticsMD, Inc. (NYSE MKT:TXMD), a women’s healthcare company
("TherapeuticsMD" or the "Company"), announced today that it has
initiated the SPRY Trial, a randomized, placebo-controlled phase 3
clinical trial designed to evaluate the safety and efficacy of TX
12-002-HR, its oral progesterone candidate for secondary amenorrhea, a
condition treated to maintain fertility in young premenopausal women.
Clinical endpoints of the SPRY Trial include withdrawal bleeding and
complete secretory change in three consecutive cycles. The trial is
designed to enroll approximately 180 patients in the United States and
is expected to be completed in late 2014.
TX 12-002-HR is a natural progesterone formulation without the
potentially allergenic component of peanut oil, which is contained in
currently available oral progesterone formulations. This investigational
product is chemically identical to the hormone that naturally occurs in
a woman’s body.
Robert G. Finizio, Chief Executive Officer and Co-founder, said, "Based
on its increased bioavailability, we believe that our oral progesterone
candidate may provide a safe and effective treatment for secondary
amenorrhea at a lower dose than oral therapies that are currently
approved by the Food and Drug Administration. If approved, we believe
our lower-dose bioidentical progesterone, with its non-allergenic
formulation, would have a significant competitive advantage. We look
forward to completing enrollment and reporting the results of the SPRY
Trial after the 12-week treatment phase."
Secondary amenorrhea is defined as the absence of menses for three
months in a woman with previously normal menstruation. Causes include
hormonal disturbances from the hypothalamus and the pituitary gland,
polycystic ovarian syndrome, premature menopause, and intrauterine scar
formation.
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.
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 design, the timing, and the
size of enrollment in the SPRY Trial, as well as the ultimate results of
the SPRY Trial; the Company’s belief that TX 12-002-HR may provide a
safe and effective treatment for secondary amenorrhea at a lower dose
versus currently approved oral therapies; the Company’s belief that if
approved by the FDA, the Company’s oral progesterone candidate would
have a significant competitive advantage; and the size of the hormone
therapy 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