Currently Enrolling Trials
Uceris (budesonide) is an oral, extended-release formulation of budesonide, a synthetic corticosteroid. It was formulated to delay the release of the active ingredient until the tablet reaches the indicated intestinal location where the controlled dissolution begins, where it decreases inflammation in the digestive tract. Budesonide retains the effectiveness of classical corticosteroids, but with reduced side effects due to its targeted controlled release in the colon with minimal systemic absorption.
Uceris is specifically indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Mechanism of Action
Uceris (budesonide) is an oral, extended-release formulation of budesonide, a synthetic corticosteroid. The formulation contains budesonide in an extended-release tablet core. The tablet core is enteric coated to protect dissolution in gastric juice which delays budesonide release until exposure to a pH > 7 in the small intestine. Upon disintegration of the coating, the core matrix provides extended release of budesonide in a time dependent manner.
Adverse events associated with the use of Uceris may include, but are not limited to, the following:
- decreased blood cortisol
- upper abdominal pain
- abdominal distension
- urinary tract infection
Uceris is supplied as a tablet for oral administration. The recommended dose is 9 mg taken orally once daily in the morning with or without food for up to eight weeks. Uceris should be swallowed whole and not chewed, crushed or broken.
Clinical Trial Results
The FDA approval of Uceris was based on two similarly-designed, randomized, double-blind, placebo-controlled studies in a total of 970 adults with active, mild to moderate ulcerative colitis, defined as an Ulcerative Colitis Disease Activity Index (UCDAI of >4 and <10). The baseline median UCDAI score in both studies was 7. In both studies, the subjects received Uceris 9 mg and 6 mg or placebo and included an active reference arm (a mesalamine 2.4 g in study 1; and a budesonide 9 mg not approved for the treatment of UC in study 2). The primary endpoint was induction of remission after eight weeks of treatment. Remission was defined as a UCDAI score of <1. In both studies, Uceris 9 mg extended-release tablets demonstrated superiority to placebo in inducing remission (p<0.025).