Santarus Inc. (SNTS) Announces Publication in Gut of Results From UCERIS (budesonide) European Pivotal Clinical Study
3/18/2013 10:24:14 AM
SAN DIEGO--(BUSINESS WIRE)--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.