Once-daily MMX Mesalamine for the Treatment of Mild-to-moderate Ulcerative Colitis

Overview

Journal Ther Clin Risk Manag

Publisher Dove Medical Press

Date 2008 May 14

PMID 18473016

Citations 7

Authors

Prashant Kedia

Russell D Cohen

Affiliations

Soon will be listed here.

Abstract

First-line therapies in the treatment of patients with mild-to-moderate ulcerative colitis are sulfasalazine or one of the mesalamine derivatives. Mesalamine is popular given its safety profile and reasonable efficacy in many patients. However, compliance is poor with regimens demanding large number of pills dosed multiple times a day and non-compliance has been correlated with disease relapse. Mesalamine requires direct contact with the inflamed colonic mucosa. To avoid proximal absorption, a variety of delivery systems has been utilized to time the release of active mesalamine to the areas affected by colitis. The most common mesalamine release mechanisms include azo-bond prodrug carriers, pH-dependent dissolution, and moisture-sensitive product dispersion. Novel technology has resulted in the development and FDA-approval of a multi-matrix release (MMX) mesalamine. Pharmacodynamic studies suggest a reliable drug delivery system with homogenous release throughout the entire colon. By incorporating the largest amount of mesalamine (1.2 g) per pill, this new product dramatically decreases the number of pills needed to attain a therapeutic daily dosage, and is the first agent approved at once-daily dosing. These factors are expected to increase patient compliance with prescribed mesalamine dosing, and in turn decrease relapse rates of active ulcerative colitis.

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References

Riley S, Mani V, GOODMAN M, Herd M, Dutt S, Turnberg L . Comparison of delayed-release 5-aminosalicylic acid (mesalazine) and sulfasalazine as maintenance treatment for patients with ulcerative colitis. Gastroenterology. 1988; 94(6):1383-9. DOI: 10.1016/0016-5085(88)90677-4. View

Farmer R, Easley K, RANKIN G . Clinical patterns, natural history, and progression of ulcerative colitis. A long-term follow-up of 1116 patients. Dig Dis Sci. 1993; 38(6):1137-46. DOI: 10.1007/BF01295733. View

Burress G, Musch M, Jurivich D, Welk J, Chang E . Effects of mesalamine on the hsp72 stress response in rat IEC-18 intestinal epithelial cells. Gastroenterology. 1997; 113(5):1474-9. DOI: 10.1053/gast.1997.v113.pm9352849. View

Hanauer S, Sandborn W, Kornbluth A, Katz S, Safdi M, Woogen S . Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005; 100(11):2478-85. DOI: 10.1111/j.1572-0241.2005.00248.x. View

Sutherland L, MacDonald J . Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006; (2):CD000544. DOI: 10.1002/14651858.CD000544.pub2. View

Safdi M, DeMicco M, Sninsky C, Banks P, Wruble L, DEREN J . A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis. Am J Gastroenterol. 1997; 92(10):1867-71. View

Ardizzone S, Doldo P, Ranzi T, Sturniolo G, Giglio L, Annese V . Mesalazine foam (Salofalk foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalk enema. The SAF-3 study group. Ital J Gastroenterol Hepatol. 2000; 31(8):677-84. View

Kovvali G, Das K . Molecular mimicry may contribute to pathogenesis of ulcerative colitis. FEBS Lett. 2005; 579(11):2261-6. DOI: 10.1016/j.febslet.2005.02.073. View

Fallingborg J, Christensen L, Ingeman-Nielsen M, Jacobsen B, Abildgaard K, Rasmussen H . pH-profile and regional transit times of the normal gut measured by a radiotelemetry device. Aliment Pharmacol Ther. 1989; 3(6):605-13. DOI: 10.1111/j.1365-2036.1989.tb00254.x. View

10.

DAlbasio G, Pacini F, CAMARRI E, Messori A, Trallori G, Bonanomi A . Combined therapy with 5-aminosalicylic acid tablets and enemas for maintaining remission in ulcerative colitis: a randomized double-blind study. Am J Gastroenterol. 1997; 92(7):1143-7. View

11.

Miner P, Hanauer S, Robinson M, Schwartz J, Arora S . Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis. Pentasa UC Maintenance Study Group. Dig Dis Sci. 1995; 40(2):296-304. DOI: 10.1007/BF02065413. View

12.

Lim W, Hanauer S . Controversies with aminosalicylates in inflammatory bowel disease. Rev Gastroenterol Disord. 2004; 4(3):104-17. View

13.

De Vos M, Verdievel H, Schoonjans R, Praet M, Bogaert M, Barbier F . Concentrations of 5-ASA and Ac-5-ASA in human ileocolonic biopsy homogenates after oral 5-ASA preparations. Gut. 1992; 33(10):1338-42. PMC: 1379600. DOI: 10.1136/gut.33.10.1338. View

14.

Gendre J, Mary J, Florent C, Modigliani R, Colombel J, Soule J . Oral mesalamine (Pentasa) as maintenance treatment in Crohn's disease: a multicenter placebo-controlled study. The Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID). Gastroenterology. 1993; 104(2):435-9. DOI: 10.1016/0016-5085(93)90411-5. View

15.

Green J, Lobo A, HOLDSWORTH C, Leicester R, Gibson J, Kerr G . Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. The Abacus Investigator Group. Gastroenterology. 1998; 114(1):15-22. DOI: 10.1016/s0016-5085(98)70627-4. View

16.

Sutherland L, MacDonald J . Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006; (2):CD000543. DOI: 10.1002/14651858.CD000543.pub2. View

17.

Wright J, OKeefe E, Cuming L, Jaskiewicz K . Olsalazine in maintenance of clinical remission in patients with ulcerative colitis. Dig Dis Sci. 1993; 38(10):1837-42. DOI: 10.1007/BF01296107. View

18.

Mansfield J, HOLDEN H, Tarlow J, Di Giovine F, McDowell T, Wilson A . Novel genetic association between ulcerative colitis and the anti-inflammatory cytokine interleukin-1 receptor antagonist. Gastroenterology. 1994; 106(3):637-42. DOI: 10.1016/0016-5085(94)90696-3. View

19.

Sutherland L, Martin F, Bailey R, Fedorak R, Poleski M, Dallaire C . A randomized, placebo-controlled, double-blind trial of mesalamine in the maintenance of remission of Crohn's disease. The Canadian Mesalamine for Remission of Crohn's Disease Study Group. Gastroenterology. 1997; 112(4):1069-77. DOI: 10.1016/s0016-5085(97)70117-3. View

20.

Kane S, Cohen R, Aikens J, Hanauer S . Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001; 96(10):2929-33. DOI: 10.1111/j.1572-0241.2001.04683.x. View