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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
The investigational drug UCERIS is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes proprietary MMX
® multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.
About Ulcerative Colitis
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 normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. According to the Crohn’s & Colitis Foundation of America, IBD affects an estimated 1.4 million Americans.