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MMX® Mesalazine

A Review of its Use in the Management of Mild to Moderate Ulcerative Colitis

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Abstract

The Multi MatriX system (MMX®) formulation of mesalazine (Lialda®; Mesavancol®; Mezavant®) [henceforth referred to as MMX mesalazine] is an oral, high-dose, once-daily, gastro-resistant, prolonged-release formulation indicated for use in patients with mild to moderate ulcerative colitis. Mesalazine has numerous anti-inflammatory effects on the mucosa of the colon, parts of which are frequently inflamed in ulcerative colitis. MMX mesalazine is believed to act topically.

Therapy with MMX mesalazine 2.4 or 4.8 g once daily for 8 weeks was superior to placebo in inducing clinical and endoscopic remission in patients with mild to moderate ulcerative colitis. In 12-month maintenance trials, MMX mesalazine 2.4 g/day maintained remission in about two-thirds of patients and was as effective as Asacol® 2.4 g/day (another oral formulation of mesalazine) as maintenance therapy. In general, MMX mesalazine was well tolerated in both short- and long-term clinical trials; its tolerability profile did not differ clinically to that of placebo or Asacol®. The majority of adverse events reported in clinical trials were gastrointestinal in nature. Therefore, MMX mesalazine appears to be a valuable option in the management of patients with mild to moderate ulcerative colitis.

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Authors and Affiliations

  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Lily P. H. Yang & Paul L. McCormack

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  1. Lily P. H. Yang
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Correspondence to Lily P. H. Yang.

Additional information

Various sections of the manuscript reviewed by: H. Asakura, Department of Internal Medicine, Nipponkoukann Hospital, Kanagawa, Japan; S. Campbell, Department of Gastroenterology, Manchester Royal Infirmary, Manchester, England; R. Caprilli, University of Rome ‘La Sapienza’, Rome, Italy; R.W. Leong, Department of Gastroenterology and Hepatology, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia; A. Lügering, Medizinisches Versorgungszentrum Portal 10, Münster, Germany; A. Nilsson, Department of Clinical Sciences, Gastroenterology and Nutrition, Lund University, Lund, Sweden; C. Prantera, Department of Gastroenterology, Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy; D.B. Sachar, Division of Gastroenterology, Mount Sinai School of Medicine, New York, New York, USA.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘mesalazine’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase (a proprietary database) search terms were ‘mesalazine’ or ‘mesalamine’ and ‘ulcerative colitis’. Searches were last updated 20 January 2011.

Selection: Studies in patients with ulcerative colitis who received mesalazine. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Mesalazine, mesalamine, 5-aminosalicylic acid, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Yang, L.P.H., McCormack, P.L. MMX® Mesalazine. Drugs 71, 221–235 (2011). https://doi.org/10.2165/11205870-000000000-00000

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