Santarus's budesonide MMX drug shows positive result for active ulcerative colitis

Nov 8 2010

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating 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>

“We plan to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”

"Positive top-line results from the European Phase III study are consistent with those from the U.S. Phase III study that we announced in late September. Both studies indicate that the higher, 9 mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis," said Gerald T. Proehl, president and chief executive officer of Santarus. "We plan to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study."

As specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.025 was required to achieve statistical significance for the comparison of each budesonide MMX dosage strength (9 mg and 6 mg) with placebo.

The intent-to-treat (ITT) population was pre-defined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice (GCP) violations or major entry criteria violations.

Source: Santarus, Inc.