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
- 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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