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

Santarus Announces Publication In Gut Of Results From UCERIS (budesonide) European Pivotal Clinical Study

Santarus, Inc. (NASDAQ: SNTS) today announced that results from its CORE II clinical study, one of two of the company’s pivotal Phase III clinical studies with UCERIS (budesonide) extended release tablets in patients with ulcerative colitis, have been published online in the peer-reviewed journal Gut. The article titled, Once-daily budesonide MMX ® in active mild-to-moderate ulcerative colitis: results from the randomized CORE II study can be found online at http://gut.bmj.com/.

The results from CORE II indicate that UCERIS 9 mg had a statistically significant benefit over placebo in the primary endpoint of inducing combined clinical and endoscopic remission at week 8 among patients with active, mild to moderate ulcerative colitis. A total of 410 patients across four treatment groups (placebo, UCERIS 9 mg, UCERIS 6 mg and Entocort EC ® 9 mg) were evaluated for efficacy in the CORE II study. The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was significantly greater than that seen in the placebo group (17.4% vs. 4.5%, p= 0.0047; odds ratio (OR): 4.49). The U.S. Food and Drug Administration (FDA) approved UCERIS 9 mg for the induction of remission in patients with active, mild to moderate ulcerative colitis on January 14, 2013.

“UCERIS 9 mg looks like a useful treatment option for the induction of remission in patients with active, mild to moderate ulcerative colitis,” said Simon P. L. Travis, M.D., Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom and lead author of the article in Gut.

Efficacy endpoints were prespecified in the statistical analysis plan to be analyzed in the modified intention to treat (ITT) population (all randomized patients who received at least one dose of study medication, with active histological disease at baseline and no major violations of Good Clinical Practices (GCP) or entry criteria (i.e., infectious colitis)), consistent with the 2008 European Medicines Agency guidelines on clinical trials of active ulcerative colitis. Active disease was determined via a central histopathologist.

1 of 4

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 16,987.51 -61.49 -0.36%
S&P 500 1,985.54 -11.91 -0.60%
NASDAQ 4,567.5980 -24.2080 -0.53%

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