Abstract:
: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.
journal_name
Drugsjournal_title
Drugsauthors
Hoy SMdoi
10.1007/s40265-015-0396-8subject
Has Abstractpub_date
2015-05-01 00:00:00pages
879-86issue
8eissn
0012-6667issn
1179-1950journal_volume
75pub_type
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