Santarus Inc (SNTS)

[surf1944]

1:05AM Santarus provides supportive top-line results from Budesonide MMX extended use study (SNTS) 2.97 : Co announces that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application for budesonide MMX 9 mg to the FDA for the induction of remission of mild or moderate active ulcerative colitis. A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of budesonide MMX 6 mg. Top-line results indicate: The frequency of treatment related adverse events for budesonide MMX 6 mg (21.0%) was similar to placebo (21.3%). Mean morning plasma Cortisol levels remained within normal limits at all visits for both budesonide MMX 6 mg and placebo. There were no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end-of-study between budesonide MMX 6 mg and placebo.