Santarus, a specialty biopharmaceutical company focused on acquiring, developing, and commercializing proprietary products, announced that the safety and efficacy results concerning the investigational drug UCERIS™ (budesonide) 6 mg tablets (previously referred to as budesonide MMX®) in a Phase III, double-blind, multicenter, placebo-controlled 12 month extended use study will be featured in four poster presentations at the Digestive Convention Center on May 19 – 22, 2012.
The study involved 123 patients, and was performed to evaluate the long-term safety and tolerability of UCERIS 6 mg. Additionally, the study assessed the effectiveness of UCERIS 6 mg in the maintenance of remission of ulcerative colitis compared to placebo, but the study was not designed to show statistical significance.
The poster presentation schedule is shown below:
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 an innovative, patented, oral tablet formulation, which utilizes proprietary MMX® multi-matrix system technology and is designed to result in the measured release and distribution of budesonide throughout the entire 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. Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A., is collaborating with Santarus on the development of UCERIS.
For more information, please visit www.santarus.com
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