- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase III Results for Extended-Release Budesonide (Uceris) in Ulcerative Colitis
Drug significantly more effective than placebo in inducing remission (Mar. 18)
Results from a recent phase III study of budesonide (Uceris, Santarus, Inc.) extended-release tablets in patients with ulcerative colitis have been published online in Gut.
In findings from the COlonic RElease Budesonide for the Treatment of Mild to Moderate Ulcerative Colitis II (CORE II) trial, extended-release budesonide 9 mg showed a statistically significant benefit over placebo in inducing combined clinical and endoscopic remission at week 8 (the study’s primary endpoint) among patients with active, mild-to-moderate ulcerative colitis. A total of 410 patients were randomly assigned to treatment with placebo, extended-release budesonide 9 mg, extended-release budesonide 6 mg, or standard budesonide (Entocort EC, AstraZeneca) 9 mg. The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the group given extended-release budesonide 9 mg was significantly greater than that observed in the placebo group (17.4% vs. 4.5%, respectively; P = 0.0047).
The FDA approved Uceris (extended-release budesonide) 9 mg for the induction of remission in patients with active, mild-to-moderate ulcerative colitis on January 14, 2013. The drug is taken once daily in the morning with or without food for up to 8 weeks.
Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the colon’s normal function. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, 700,000 people in the U.S. have ulcerative colitis.