Study results showed that Budesonide MMX 9mg taken once daily met the primary endpoint of superiority to placebo in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment.
Cosmo Pharmaceuticals CEO Mauro Ajani said that they were very pleased to announce positive results for the US study with the 9mg dose, which further validate the ability of MMX technology to deliver an active pharmaceutical ingredient directly and efficiently to the colon.
Santarus president and CEO Gerald Proehl said that the positive results were a major step toward the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for Budesonide MMX 9mg for the induction of remission of mild or moderate active ulcerative colitis.
“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,” Proehl said.
As per the statistical analysis plan submitted by the companies, to the FDA for each Phase III study, to achieve statistical significance the Budesonide MMX 9mg and 6mg treatment arms required a separate analysis at a p-value of 0.025 compared with the placebo group.