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Archived: budesonide (Cortiment)

Advice

following an abbreviated submission:

budesonide (Cortiment®) is not recommended for use within NHS Scotland.

Indication under review: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient.

In two, phase III, placebo-controlled studies, significantly higher proportions of patients achieved clinical and colonoscopic remission at week 8 with budesonide (Cortiment®) 9mg once daily compared to placebo. However, similar clinical effectiveness with the reference product, a rectal formulation of budesonide, has not been demonstrated.
 

Drug Details

Drug Name: budesonide (Cortiment)
SMC Drug ID: 1093/15
Manufacturer: Ferring Pharmaceuticals Ltd
Indication: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient.
BNF Category:
Sub Category: 1.5 Chronic bowel disorders
Submission Type: Abbreviated Submission
Status: Not Recommended
Date Advice Published: 12 October 2015

Current Advice

Resubmission 10 October 2016

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