Santarus second budesonide MMX Phase III clinical study meets primary endpoint

The primary endpoint was the achievement of clinical remission, defined as a UCDAI score = 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and = 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (an indicator of mucosal inflammation).

The second budesonide MMX Phase III clinical study was conducted in Europe in collaboration with Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals.

Santarus said that 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 6mg) with placebo.

Santarus president and CEO Gerald Proehl said that positive top-line results from the European Phase III study are consistent with those from the US Phase III study that they announced in late September.

"Both studies indicate that the higher, 9mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis," Proehl said.

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