This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

TherapeuticsMD Reports Positive PK Study Results For Its Estradiol Vaginal Capsule VagiCap™ (TX 12-004-HR) For Treatment Of Vulvar Vaginal Atrophy (VVA)

Stocks in this article: TXMD

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.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,805.41 +127.51 0.76%
S&P 500 1,964.58 +13.76 0.71%
NASDAQ 4,483.7150 +30.9230 0.69%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs