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