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news.Santarus has announced positive data from an open-label study, intended to assess the efficacy and safety of investigational drug, Uceris (budesonide) 9 mg tablets in patients with mild or moderate active ulcerative colitis.
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Uceris is a locally acting corticosteroid available in a novel, patented, oral tablet formulation, indicated for induction of remission of active ulcerative colitis.
Santarus in collaboration with Cosmo Technologies conducted an open-label clinical study with Uceris, as a companion study to a pivotal Phase III clinical study in patients with mild or moderate active ulcerative colitis.
The primary endpoint of the trial includes induction of clinical and endoscopic remission, estimated by an Ulcerative Colitis Disease Activity Index (UCDAI).
Santarus medical affairs and pharmacovigilance senior vice president David Ballard said the open-label data will be used to support the new drug application (NDA) for Ucceris 9 mg.
"We are on track to submit the UCERIS NDA to the FDA later this month," Ballard added.