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

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

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

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 17,798.49 -14.90 -0.08%
S&P 500 2,090.11 +1.24 0.06%
NASDAQ 5,127.5250 +11.3820 0.22%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs