Apriso granulated mesalamine: Phase III data

In a double-blind, U.S. Phase III trial in 305 patients with UC in remission, 1.5 g once-daily Apriso met the primary endpoint of a significantly higher proportion of relapse-free patients at 6 months vs. placebo (78.9% vs. 58.3%, p<0.001). Apriso also met the secondary endpoints of significantly improving SDAI scores for rectal bleeding (p=0.008), physician's rating of disease activity (p=0.005), and stool frequency from baseline to 6 months vs. placebo (p=0.005).

Additionally, Apriso significantly improved mean SDAI total score from baseline to 6 months vs. placebo (p=0.025). Furthermore, a significantly higher proportion of Apriso-treated patients were classified as treatment successes, and remained relapse-free over 6 months vs. placebo (p=0.003 and p<0.001, respectively). Apriso missed the secondary endpoint of significantly improving SDAI score for mucosal appearance from baseline to 6 months vs. placebo (p=0.098). Data were published in Alimentary Pharmacology & Therapeutics. ...