This Day On The Street
Continue to site
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

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

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

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,719.92 -78.57 -0.44%
S&P 500 2,080.41 -9.70 -0.46%
NASDAQ 5,108.6660 -18.8590 -0.37%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs