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

Palatin Technologies Reports Positive Results For Phase 2B Bremelanotide Female Sexual Dysfunction Trial

Stocks in this article: PTN

Data analysis of the individual 0.75 mg, 1.25 mg and 1.75 mg bremelanotide doses each showed clinically meaningful improvement for the primary endpoint and key secondary endpoints, with the 1.75 mg dose achieving statistical significance for the endpoints cited above.

Jeff Edelson, M.D., Chief Medical Officer for Palatin stated, "These data provide an important demonstration of the safety and efficacy of bremelanotide and suggest its potential utility for the treatment of FSD in premenopausal women. Moreover, the trial provides important data that will be instrumental in planning Phase 3 clinical trials and activities. We look forward to working closely with our expert advisors, and the FDA, to identify next steps in the late stage clinical development of this exciting drug."

"These safety and efficacy trial results are very encouraging and clearly warrant further clinical testing of bremelanotide in this patient population. Despite the pressing need for such treatments, there are presently no FDA approved therapies for the treatment of female sexual disorders, conditions with major negative health impacts on patients," said Sheryl Kingsberg, Ph.D., Division Chief, OB/GYN Behavioral Medicine, UH Case Medical Center, and a clinical investigator on the study.

Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 395 patients. A total of 26 patients discontinued from the study based on predefined blood pressure criteria: these patients were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 patients discontinued from the study due to adverse events (N=12, Placebo: 2, bremelanotide arms 0.75 mg: 0, 1.25 mg: 4, 1.75 mg: 6). Adverse events that most commonly led to discontinuation were nausea and emesis.

The study was supervised by an independent Data Safety Monitoring Board. No serious adverse events were attributed to bremelanotide during the trial.

2 of 3

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 16,380.41 +263.17 1.63%
S&P 500 1,886.76 +24.00 1.29%
NASDAQ 4,258.4380 +41.0480 0.97%

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