Once-Daily, High-Concentration MMX Mesalamine in Active Ulcerative Colitis

Abstract

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. A delayed-release oral mesalamine (ASACOL; Procter & Gamble, Cincinnati, OH) reference arm was included.Methods: Three hundred forty-three patients with active, mild-to-moderate ulcerative co..