TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that it has
initiated a Phase I study of its TX- 12-004-HR estradiol VagiCap™ for
vulvar and vaginal atrophy (“VVA”). Already this study has enrolled 44%
of the planned 50-patient cohort.
Robert G. Finizio, Co-Founder and Chief Executive Officer, said, “We
believe this is a promising drug candidate based on our unique VagiCap
delivery technology. Last year, estrogen sales for VVA were over $800
million and the category is growing rapidly, making this a particularly
attractive opportunity for TherapeuticsMD. We are pleased with the rapid
rate of enrollment in this study and look forward to reporting results.”
The Phase I study is designed to show pharmacokinetics levels and
measure the effect of TX- 12-004-HR on certain clinical endpoints,
including pH levels, vaginal cytology, and vulvar and vaginal pain and
itching, which is the most bothersome symptom of VVA.
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. The potential market for pharmacy-compounded, bioidentical HT
products is estimated to be approximately $1.5 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 manufacture and distribute branded and generic prescription prenatal
vitamins, as well as over-the-counter vitamins and cosmetics, under our
vitaMedMD® and BocaGreenMD™ brands. We are currently
developing advanced hormone therapy pharmaceutical products designed to
alleviate the symptoms of and reduce the health risks resulting from
menopause-related hormone deficiencies. We are also evaluating various
other potential indications for our hormone technology, including oral
contraception, preterm birth, vulvar and vaginal atrophy, and premature
ovarian failure. More information is available at the following
websites: www.therapeuticsmd.com,
www.vitamedmd.com,
www.vitamedmdrx.com,
and www.bocagreenmd.com.
vitaMedMD® is a registered trademark and TherapeuticsMD™ and
BocaGreenMD™ are trademarks of TherapeuticsMD, Inc.
Except for the historical information contained herein, the matters
set forth in this press release, including statements regarding the
Company’s belief that its TX-12-004 estradiol VagiCap is a promising
drug candidate based on the Company’s delivery technology, that it is
now positioned to move three product candidates into late-stage clinical
trials, the Company’s expectations with respect to the timing of its
clinical trials, and the status of the pharmacokinetic studies with TX
12-004HR 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 2013