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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

FDA Places New Heart-Safety Hurdle in Path of Opioid Constipation Drugs

Injectable Relistor was approved in 2008 but only for the limited indication of treating opioid-induced constipation in critically ill patients in hospice or palliative care. Relistor use beyond four months was not studied or approved.

In August 2011, Salix and Progenics filed an application with FDA seeking to expand Relistor's label to allow long-term treatment of OIC in all patients with non-cancer pain. The filing included data from a phase III, open-label safety study in which more than 1,000 patients were treated with Relistor for 48 weeks.

In July, FDA rejected Relistor and told Salix and Progenics that additional clinical work would be required before the drug could be approved for OIC. It was at an early October meeting to follow up on the rejection that FDA officials told Salix about the agency's concerns with the cardiovascular safety of the OIC drug class, the company said.

Salix admits that it has not conducted studies of Relistor designed to specifically measure the drug's risk to heart safety. However, data encompassing 4,000 patients treated with Relistor and 1,000 patients taking a placebo has not detected any such signal, said Forbes on Wednesday's conference call.

Forbes added that he's not sure a heart-safety trial of Relistor as requested by FDA is even possible to conduct given the relative paucity of cardiovascular events observed in patients to date. Salix continues to negotiate with the FDA but at this point, Relistor for OIC is in regulatory limbo. Clinical development of a Relistor pill, also for OIC, is also on hold.

Nektar can ill afford any delays in the development of its OIC drug naloxegol. Under a partnership agreement with AstraZeneca, Nektar expects to receive $95 million in cash when naloxegol is submitted for approval in the U.S. and Europe. AstraZeneca will pay Nektar another $140 million if naloxegol is approved and launched commercially.

Whether or not FDA intends to force Nektar and AstraZeneca to conduct another safety study of naloxegol is not clear.

On Friday, Nektar surprised investors with an early filing of its 10-Q for the third-quarter, which included a new risk statement regarding naloxegol:

"For example, we understand that the FDA is exploring whether there is any evidence of a potential cardiovascular class effect related to opioid withdrawal associated with mu-opioid antagonists and naloxegol is a mu-opioid antagonist. Although AstraZeneca is conducting comprehensive safety studies for naloxegol as part of the KODIAC development program, the health authorities retain significant discretion over regulatory requirements which remain very uncertain and difficult to predict prior to obtaining approval."

2 of 3

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
AZN $66.21 -2.90%
CBST $101.94 0.14%
NKTR $12.90 -3.00%
PGNX $6.95 1.90%
SLXP $157.88 0.28%


DOW 17,895.15 -240.57 -1.33%
S&P 500 2,077.25 -23.79 -1.13%
NASDAQ 4,938.8860 -43.9230 -0.88%

Partners Compare Online Brokers

Free Reports

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