Sep 30 2010
Santarus, Inc. (NASDAQ:SNTS) and Cosmo Pharmaceuticals S.p.A. (SIX:COPN) today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.
"These positive results are a major step toward the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for budesonide MMX 9 mg for the induction of remission of mild or moderate active ulcerative colitis," said Gerald T. Proehl, president and chief executive officer of Santarus. "Assuming positive results in the European clinical study we plan to submit the NDA in the second half of 2011 following the completion of an ongoing double-blind, placebo-controlled extended use study."
Mauro Ajani, chief executive officer of Cosmo Pharmaceuticals, said, "We are very pleased to announce positive results for the U.S. study with the 9 mg dose, which further validate the ability of our MMX technology to deliver an active pharmaceutical ingredient directly and efficiently to the colon. We are expecting to have the top-line results from the European Phase III study available in November."
Under the statistical analysis plan submitted to the FDA for each Phase III study, to achieve statistical significance the budesonide MMX 9 mg and 6 mg treatment arms required a separate analysis at a p-value of 0.025 compared with the placebo group. The intent-to-treat (ITT) population in the pre-defined statistical analysis plan was all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, or due to Good Clinical Practice (GCP) violations or major entry criteria violations.
SOURCE Santarus, Inc.
Landmark study highlights growing pediatric IBD rates across the U.S.