MMX mesalamine (Shire) fails Phase III study for Diverticulitis

Shire has announced results of the PREVENT2 trial, a phase III investigational study of once-daily SPD476, MMX mesalamine (Lialda-USA; Mezavant XL-EU) in patients with a history of Diverticulitis. The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of Diverticulitis over a 2-year treatment period. In addition, SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study. PREVENT 1 trial was similar in design to PREVENT 2 and will report later in the year. Although the results of the second trial are pending, it is the current intention of Shire not to pursue a regulatory filing for this indication for MMX mesalamine.