Once-daily mesalamine granules for ulcerative colitis

Abstract

Mesalamine extended-release capsules (Apriso™ [Salix Pharmaceuticals, Raleigh, NC, USA]) are the first once-daily mesalamine preparation approved by the US FDA for the maintenance of remission of ulcerative colitis (UC). Each mesalamine extended-release capsule contains granules of a mesalamine-polymer matrix that are coated with a pH-sensitive resin. This design begins releasing mesalamine (0.375 g) once the pH is more than 6 in the ileum and colon. Two clinical trials have reported that mesalamine extended-release capsules (1.5 g/day) maintained remission in 79% of patients with UC who were in clinical remission. Reported adherence with mesalamine extended-release capsules once daily was high (>90%) in these studies. This article examines the efficacy and safety of mesalamine extended-release capsules in the maintenance of remission in patients with UC.

Keywords::

• adherence
• granules
• mesalamine
• remission
• ulcerative colitis

Acknowledgements

Salix Pharmaceuticals provided copies of published trials and abstracts that studied mesalamine granules. The authors also completed an independent literature review for this manuscript.

Financial & competing interests disclosure

Alan C Moss has received research support from Procter & Gamble, UK (Asacol^®) and a speaker’s honorarium from Shire Pharmaceuticals, PA, USA (Lialda^®). Garrett Lawlor has received grant funding from Schering Plough (UK). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.