This Day On The Street
Continue to site
ADVERTISEMENT
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 Of Results From UCERIS Pivotal Study In Gastroenterology

Santarus, Inc. (NASDAQ: SNTS) today announced that results from its CORE I clinical study, one of two of the company’s pivotal Phase III clinical studies with UCERIS (budesonide) in ulcerative colitis, have been published online in the journal Gastroenterology. The article titled, Once-Daily Budesonide MMX ® Extended-Release Tablets Induce Remission in Patients with Mild to Moderate Ulcerative Colitis – Results from the CORE I Study can be found online at www.gastrojournal.org.

The results from CORE I indicate that the investigational drug UCERIS 9 mg had a statistically significant benefit over placebo in the primary endpoint of combined clinical and endoscopic remission at week 8 among patients with active, mild to moderate ulcerative colitis. The U.S. Food and Drug Administration (FDA) is currently reviewing the company’s New Drug Application (NDA) for UCERIS for the induction of remission in patients with active, mild to moderate ulcerative colitis with a target action date of January 16, 2013.

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 (17.9% vs. 7.4%, p= 0.0143; odds ratio (OR): 2.71). The combined clinical and endoscopic remission rate for UCERIS 6 mg (13.2% vs 7.4%, p= 0.1393; OR: 1.90) and for the reference drug Asacol ® (mesalamine) 2.4 g (12.1% vs 7.4%, p= 0.2200; OR: 1.71) were numerically greater than placebo, but the differences were not statistically significant. These results are summarized in the table below.

 

     

Placebo

n= 121

    Uceris

9 mg

n= 123

    Uceris

6 mg

n= 121

    Asacol

2.4 g

n= 124

Combined Clinical and Endoscopic Remission, %       7.4%     17.9%     13.2%     12.1%
P-value             0.0143*     0.1393     0.2200
Odds ratio             2.71     1.90     1.71

*Statistically significant (p < 0.025)

1 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
Only $9.95
14-Days Free
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!
SYM TRADE IT LAST %CHG

Markets

DOW 18,037.97 -42.17 -0.23%
S&P 500 2,108.92 -8.77 -0.41%
NASDAQ 5,060.2460 -31.8390 -0.63%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs