This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

[video] Orexigen Weight-Loss Pill Passes Safety Hurdle

Stocks in this article: OREX VVUS ARNA

Orexigen Therapeutics  (OREX) said Monday that its obesity pill Contrave passed a key heart-safety test, allowing the company to resubmit for U.S. approval "within a few weeks."

If FDA approves Contrave, Orexigen and its marketing partner Takeda will launch the drug commercially in the third quarter of next year. Contrave would be the third obesity pill sold in the U.S., following the disappointing commercial debuts of competing drugs from Vivus  (VVUS) and Arena Pharmaceuticals (ARNA).

Orexigen shares rose 16% to $6.67 in early Monday trading. 

Obese patients taking Contrave for weight loss were found not be at an increased statistical risk for heart attacks or other heart-related side effects, according to an interim analysis of the "Light" safety study, Orexigen said. 

The FDA rejected Contrave in 2011 because of concerns that the pill might increase the risk of heart-related side effects. Orexigen conducted the "Light" study in 8,900 obese patients to demonstrate Contrave's safety. 

No details from the "Light" study were announced Monday except that the drug met the statistical requirements necessary to rule out an increased risk in heart-related side effects. Orexigen did not disclose whether Contrave was associated with a numerical increase in heart-related side effects compared to placebo. 

Contrave is a single pill containing two already-approved medicines -- naltrexone and bupropion -- which combined are designed to help people lose weight. 

Contrave is less effective than Vivus' Qsymia but superior to Arena's Belviq, based on their respective phase III clinical studies. The drugs have not been compared directly against each other in any study. 

In addition to a possible U.S. approval by June 2014, Orexigen believes Contrave could be approved in Europe before the end of 2014. European regulators have already rejected Vivus' and Arena' respective obesity pills. 

  -- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • 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