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%|
*Statistically significant (p < 0.025)
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