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Javier P Gisbert, Fernando Gomollón, Ignacio Méndez
INTRODUCTION: The prevalence of ulcerative colitis (UC) and its associated economic burden is increasing in Spain. Oral mesalazines, which are the recommended first-line treatment for mild-moderate UC, show considerable variability in their formulations and prices. OBJECTIVE: To carry out a cost-effectiveness assessment of the use of the two formulations of oral gastro-resistant modified-release mesalazine formulations marketed in Spain (Salofalk(®) and Mezavant(®)) for the phases of induction of remission and its maintenance...
March 2016: Gastroenterología y Hepatología
Adeyinka Abinusawa, Srini Tenjarla
INTRODUCTION: Oral formulations of 5-aminosalicylic acid (5-ASA) for treatment of ulcerative colitis have been developed to minimize absorption prior to the drug reaching the colon. In this study, we investigate the release of 5-ASA from available oral mesalamine formulations in physiologically relevant pH conditions. METHODS: Release of 5-ASA from 6 mesalamine formulations (APRISO®, Salix Pharmaceuticals, Inc., USA; ASACOL® MR, Procter & Gamble Pharmaceuticals UK Ltd...
May 2015: Advances in Therapy
Alvaro Goyanes, Grace B Hatton, Hamid A Merchant, Abdul W Basit
The aminosalicylate mesalazine (mesalamine) forms the mainstay of treatment in ulcerative colitis (UC), a disease for which many commercial modified-release products have been developed with the aim of providing targeted gastrointestinal release. The release profiles of five of these commercial formulations were evaluated in bicarbonate buffer using a novel dissolution model that mimics the dynamic conditions of the gastrointestinal tract. Monolithic and multi-particulate mesalazine formulations with pH-dependent and/or independent release mechanisms were evaluated (Asacol(®) 800, Octasa(®), Mezavant(®) XL, Salofalk(®), Pentasa(®)), and each of the products displayed a distinctive dissolution profile...
April 30, 2015: International Journal of Pharmaceutics
Jean Lachaine, Linnette Yen, Catherine Beauchemin, Paul Hodgkins
BACKGROUND: Although high non-adherence to medication has been noticed for ulcerative colitis (UC), little is known about adherence to mesalamine treatments and determinants that can predict adherence. The objective of this study was to assess adherence and persistence to mesalamine treatments and their potential determinants in mild to moderate UC patients in a real-life setting in Quebec, Canada. METHODS: A retrospective prescription and medical claims analysis was conducted using a random sample of mesalamine users with UC...
2013: BMC Gastroenterology
Sara N Horst, Sunanda Kane
INTRODUCTION: Ulcerative colitis (UC) is an inflammatory disease of the colon characterized by periods of active disease and remission. The pathogenesis of this disease is likely a complex interaction of genetic predisposition, environmental factors, and immune system dysregulation, and is not completely understood. A Multi-MatriX (MMX®) system formulation of mesalamine, MMX mesalamine (SPD476; Lialda®; Mesavancol®; Mezavant®), allows for high-dose, once-daily dosing for patients with mild-to-moderate UC...
October 2012: Expert Opinion on Pharmacotherapy
Kavinderjit Nanda, Alan C Moss
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon that typically manifests as diarrhea, abdominal pain, and bloody stool. Complications, such as colorectal cancer and extraintestinal manifestations, may also develop. The goals of management are to induce and maintain clinical remission and to screen for complications of this disease. Mesalamine is a 5-aminosalicylic acid compound that is the first-line therapy to induce and maintain clinical remission in patients with mild-to-moderate UC...
2012: Clinical Pharmacology: Advances and Applications
Anne Prenzler, Linnette Yen, Thomas Mittendorf, J-Matthias von der Schulenburg
BACKGROUND: The treatment of ulcerative colitis (UC) can place a substantial financial burden on healthcare systems. The anti-inflammatory compound 5-aminosalicylic acid (5-ASA; mesalazine) is the recommended first-line treatment for patients with UC. In this analysis, the incremental cost effectiveness ratio (ICER) of two oral formulations of 5-ASA (Mezavant® and Asacol®) is examined in the treatment of patients with mild-to-moderate, active UC in Germany. METHODS: A Markov cohort model was developed to assess the cost effectiveness of Mezavant compared with Asacol over a 5-year period in the German Statutory Health Insurance (SHI)...
2011: BMC Health Services Research
Lily P H Yang, Paul L McCormack
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...
January 22, 2011: Drugs
Nic Brereton, Keith Bodger, Michael A Kamm, Paul Hodgkins, Songkai Yan, Ron Akehurst
OBJECTIVES: To perform a cost-utility analysis of a new formulation of mesalazine (Mezavant XL, MMX mesalazine) versus an existing oral mesalazine (Asacol; mesalazine) from the UK National Health Service perspective. METHODS: A 5-year Markov cohort model was developed. Costs were obtained from the literature and utilities from an independent study. Uncertainty was evaluated using one-way and probabilistic sensitivity analyses (PSA). The potential effect of dosing frequency on adherence and possible long-term effects of remission maintenance on colorectal cancer (CRC) rates were also investigated...
March 2010: Journal of Medical Economics
Hala M Fadda, Hamid A Merchant, Basel T Arafat, Abdul W Basit
Bicarbonate media are reflective of the ionic composition and buffer capacity of small intestinal luminal fluids. Here we investigate methods to stabilise bicarbonate buffers which can be readily applied to USP-II dissolution apparatus. The in vitro drug release behaviour of three enteric coated mesalazine (mesalamine) products is investigated. Asacol 400 mg and Asacol 800 mg (Asacol HD) and the new generation, high dose (1200 mg) delayed and sustained release formulation, Mezavant (Lialda), are compared in pH 7...
December 1, 2009: International Journal of Pharmaceutics
W J Sandborn, M A Kamm, G R Lichtenstein, A Lyne, T Butler, R E Joseph
MMX mesalazine [LIALDA (US), MEZAVANT XL (UK and Ireland) MEZAVANT (elsewhere)] utilizes MMX Multi Matrix System (MMX) technology which delivers mesalazine throughout the colon. Two phase III studies have already evaluated MMX mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed...
July 15, 2007: Alimentary Pharmacology & Therapeutics
Michael A Kamm, William J Sandborn, Miguel Gassull, Stefan Schreiber, Lechoslaw Jackowski, Todd Butler, Andrew Lyne, David Stephenson, Mary Palmen, Raymond E Joseph
BACKGROUND & AIMS: SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a novel, once-daily, high-strength (1.2 g/tablet) formulation of mesalamine, utilizing MMX Multi Matrix System (MMX) technology designed to deliver the active drug throughout the colon. We performed a double-blind, multicenter study, comparing MMX mesalamine vs placebo for the treatment of active ulcerative colitis...
January 2007: Gastroenterology
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