Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Drug Information » FDA Approved Drugs » 2013
Medical Areas: Gastroenterology | Family Medicine

View By:YearCompanyConditionsTherapeutic AreasDrug Names

Uceris (budesonide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Santarus
Approval Status: Approved January 2013
Treatment Area: ulcerative colitis

General Information

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.

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 8 weeks. Uceris should be swallowed whole and not chewed, crushed or broken.

Clinical Results

FDA Approval
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 8 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).

Side Effects

Adverse events associated with the use of Uceris may include, but are not limited to, the following:

  • headache
  • nausea
  • decreased blood cortisol
  • upper abdominal pain
  • fatigue
  • flatulence
  • abdominal distension
  • acne
  • urinary tract infection
  • arthralgia
  • constipation

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.

Literature References

Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology 2012 Nov;143(5):1218-26

Additional Information

For additional information regarding Uceris or ulcerative colitis, please visit the Santarus web page.