Santarus to present UCERIS Phase III trial data on ulcerative colitis at DDW meeting

Santarus, Inc. (NASDAQ: SNTS) today announced that safety and efficacy data from a Phase III, double-blind, multicenter, placebo-controlled 12 month extended use study with the investigational drug UCERIS (budesonide) 6 mg tablets (previously referred to as budesonide MMX®) will be featured in four poster presentations at the Digestive Disease Week (DDW®) Meeting being held at the San Diego Convention Center on May 19 - 22, 2012.

A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of UCERIS 6 mg. The extended use study also explored the efficacy of UCERIS 6 mg in the maintenance of remission of ulcerative colitis compared to placebo, but the study was not powered to show statistical significance.

The poster presentations are scheduled as follows:

Sunday, 8:00 a.m. - 5:00 p.m., May 20, 2012, Randomized Controlled Trials in IBD, San Diego Convention Center, Halls C - G

  • Su2087 - Effect of Long-Term Budesonide MMX 6 mg Use on Bone Mineral Density in Patients with Ulcerative Colitis: Results From a Phase III, 12 Month Safety and Extended Use Study
  • Su2088 - Safety Analysis of Budesonide MMX 6 mg for the Maintenance of Remission in Patients With Ulcerative Colitis: Results From a Phase III, 12 Month Safety and Extended Use Study
  • Su2080 - Efficacy of Budesonide MMX 6 mg QD for the Maintenance of Remission in Patients With Ulcerative Colitis: Results From a Phase III, 12-Month Safety and Extended Use Study

Tuesday, 8:00 a.m. - 5:00 p.m. May 22, 2012, Clinical IBD, San Diego Convention Center, Halls C - G

  • Tu1252 - Effect of Budesonide MMX 6 mg on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Patients With Ulcerative Colitis: Results From a Phase III, 12 Month Safety and Extended Use Study      

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