TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company
("TherapeuticsMD" or the "Company"), announced today the final PK
results from two studies of TX 12-004-HR, a rapidly acting vaginal
preparation capsule versus Novo Nordisk’s Vagifem® (estradiol
vaginal tablet). ESTR-1K-499 was an open label, single dose crossover,
relative bioavailability study comparing 10µg of TX 12-004-HR to 10µg of
Vagifem. ESTR-1K-500 was the study with the same design, but compared
25µg of TX 12-004-HR to 25µg of Vagifem. Study results showed
substantially lower systemic estradiol exposure of TX 12-004-HR when
compared to Vagifem. In conjunction with the previously reported
efficacy of TX 12-004-HR, this PK data suggests that TX 12-004-HR may
provide therapeutic advantages over Vagifem.
Side effects associated with vaginal hormone therapy may be related to
peak concentrations or overall exposure to the hormones. The maximal
concentration of TX 12-004-HR estradiol was about half that observed
with Vagifem and the overall exposure to estradiol was approximately
one-third that observed with Vagifem. The 24-hour exposure to estradiol
in the case of 25µg dose of TX 12-004-HR was 3.3 fold lower than the
same dose of Vagifem, and in the case of 10µg dose of TX 12-004-HR was
2.6 fold lower than the same dose of Vagifem. These results would
indicate substantially less overall estradiol exposure with
TX 12-004-HR, yet the biological effects shown in the pilot phase 1
study reported in October 2013 showed statistically significant results
of quantitative endpoints, namely reduction of vaginal pH (p=0.0002) and
reduction of vaginal parabasal cells (p<0.0001) and increase in vaginal
superficial cells (p=0.0002).
Robert G. Finizio, Chief Executive Officer and Co-founder of
TherapeuticsMD, said, “We are pleased that our drug candidate appears to
have a lower systemic estradiol exposure while achieving statistically
significant clinical efficacy. Our goal is to create a faster-acting,
rapidly dissolving VagiCap with less systemic estradiol exposure in a
more elegant form. These results will be used to design a development
plan and a clinical program to be submitted to Food and Drug
Administration ("FDA") for treatment of VVA in postmenopausal women. The
VVA market is growing substantially due to increasing demands by
maturing women who are remaining sexually active longer and finding
dissatisfaction with current treatment options. We are committed to
developing this drug candidate to offer women a significant advancement
in treatment options and to meet their unmet needs,” concluded Finizio.
About TX 12-004-HR
TX 12-004-HR estradiol VagiCap is an investigational drug matching the
molecular structure of estradiol that is designed to treat moderate to
severe VVA symptoms associated with menopause. TX 12-004-HR leverages
the solubilized estradiol technology developed by TherapeuticsMD in a
unique, tear-shaped softgel capsule designed for easy intravaginal
insertion. It is the first softgel capsule for the treatment of VVA
being developed for review by the FDA.
About VVA and Market Size
According to the North American Menopause Society (NAMS), up to 50% of
postmenopausal women are estimated to be affected by this condition
resulting from the decrease in estrogen that occurs with menopause. The
U.S. Census estimates this number will exceed 50 million women in 2015.
Despite symptoms that can adversely affect quality of life, sexual
function, and urogynecologic health and that include vaginal and vulvar
pain, irritation, itching, burning, discharge, and painful intercourse,
approximately 75% of women with symptoms do not seek treatment. Source
Healthcare Analytics estimated the U.S. market for postmenopausal VVA
was over $1 billion in 2013, increasing more than 20% over the prior
year. GlobalData estimated the global market for postmenopausal VVA is
currently projected to reach $3.1 billion by 2019.
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
ultimate results of clinical development of the Company’s proposed
estradiol VagiCap drug; the Company’s belief that the PK data
suggests that TX 12-004-HR may provide therapeutic advantages over
Vagifem; the Company’s belief that the side effects associated with
vaginal hormone therapy may be related to peak concentrations or overall
exposure to the hormones; the Company’s belief that TX 12-004-HR appears
to have a lower systemic estradiol exposure while achieving
statistically significant clinical efficacy; the Company’s goal to
create a faster-acting, rapidly dissolving VagiCap with less systemic
estradiol exposure in a more elegant form; the Company’s expectation to
use these results to design a development plan and a clinical program to
be submitted to the FDA for treatment of VVA in postmenopausal women;
the Company’s belief that the VVA market is growing substantially due to
increasing demands by maturing women who are remaining sexually active
longer and finding dissatisfaction with current treatments options; the
Company’s commitment to developing this drug candidate to offer women a
significant advancement in treatment options and to meet their unmet
needs; the Company’s belief in the anticipated achievements, attributes,
and benefits of TX 12-004-HR; estimates of the percentage and number of
women to be affected by VVA; estimate of the percentage of women with
VVA symptoms that do not seek treatment for their symptoms; and the
projected size and growth potential of the global and U.S.-based VVA
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; 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,
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