Budesonide MMX(®) (Cortiment(®); Uceris(®)) is a novel once-daily oral formulation of
budesonide using Multi Matrix (MMX(®)) colonic delivery technology to permit the release of
budesonide at a controlled rate throughout the colon. It is available in the USA for the
induction of remission in patients with active, mild to moderate
ulcerative colitis, and in various European countries for the
induction of remission in patients with active, mild to moderate
ulcerative colitis where
5-aminosalicylic acid (5-ASA)
therapy is not sufficient. In three 8-week multinational, phase III studies in patients with active, mild to moderate
ulcerative colitis, once-daily
budesonide MMX(®) 9 mg, as monotherapy (CORE I and II studies) or add-on
therapy to 5-ASAs (CONTRIBUTE), was significantly more effective than placebo in inducing combined clinical and endoscopic remission. In an 8-week extension of the CORE I study, the efficacy of
budesonide MMX(®) 9 mg monotherapy was demonstrated among patients who completed the CORE I study, but did not achieve clinical remission. In phase III studies, the tolerability profile of
budesonide MMX(®) 9 mg as monotherapy or add-on
therapy to 5-ASAs was generally similar to that of placebo. Adverse events were generally mild or moderate in intensity, with exacerbation, relapse or worsening of
ulcerative colitis,
headache,
nausea,
abdominal pain and
nasopharyngitis the most frequently reported following
budesonide MMX(®) 9 mg monotherapy. Although final data from the CONTRIBUTE study are awaited, current evidence suggests
budesonide MMX(®) 9 mg extends the treatment options currently available for patients with active, mild to moderate
ulcerative colitis.