Uceris that contains a locally acting glucocorticosteroid, budesonide, in a novel oral tablet formulation has obtained FDA approval.
Santarus research and development executive vice president Wendell Wierenga said, "In our pivotal clinical studies, three times more patients achieved clinical remission and mucosal healing with UCERIS compared with patients taking placebo, and no clinically significant differences in glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment."
Uceris, developed in collaboration with Cosmo Technologies, was formulated leveraging MMX multi-matrix system colonic delivery technology.
An oral administration of one 9mg tablet per day in the morning for up to eight weeks is recommended for adult patients.
Santarus commercial operations senior vice president William Denby said 85 new sales representatives were added for the commercial launch of Uceris.
"We will use the entire sales organization to promote UCERIS and ZEGERID® (omeprazole/sodium bicarbonate) to gastroenterologists, while also continuing to promote our three diabetes/metabolic products to endocrinologists and other physicians," Denby added.