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Phase III Results Announced for Uceris (Budesonide) in Ulcerative Colitis

FDA approval decision expected in January (Sept. 27)

Santarus, Inc., based in San Diego, Calif., announced on September 27 that results from its CORE I clinical trial — one of two pivotal phase III studies of the company’s investigational drug Uceris (budesonide) in ulcerative colitis — have been published online in Gastroenterology.

In the pivotal study, Uceris 9 mg provided a statistically significant benefit compared with placebo in the primary endpoint of combined clinical and endoscopic remission at week 8 among patients with active, mild-to-moderate ulcerative colitis.

The 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.

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the colon’s normal function, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss, and frequent bowel movements. It is believed that as many as 700,000 people in the U.S. have the disease.

In the new 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 in the placebo group (17.9% vs. 7.4%, respectively; P = 0.0143). The combined clinical and endoscopic remission rates for Uceris 6 mg (13.2% vs 7.4%; P = 0.1393) and for the reference drug Asacol (mesalamine) 2.4 g (12.1% vs 7.4%; P = 0.2200) were numerically greater than that for placebo, but the differences were not statistically significant.

Uceris 6 mg and 9 mg were generally well tolerated, and the frequency of treatment-emergent adverse events was similar to that of placebo. The most frequent treatment-emergent adverse events included worsening ulcerative colitis, headache, pyrexia, insomnia, back pain, nausea, abdominal pain, diarrhea, and flatulence.

Potential glucocorticoid effects occurred in similar percentages of patients across all treatment groups. Potential glucocorticoid effects occurred in 10.1% of patients in the placebo group; in 11.8% of patients in the Uceris 9 mg group; in 5.6% of patients in the Uceris 6 mg group; and in 7.9% of patients in the Asacol group.

Uceris is an investigational drug that contains budesonide, a corticosteroid, in an oral tablet formulation that uses proprietary MMX multimatrix-system technology, which is designed to provide the controlled release and distribution of budesonide throughout the length of the colon.

For more information, visit the Santarus, Inc. Web site.

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