Table 6.

US FDA clinical efficacy criteria for mesalamine formulation approval.

Formulation	Date of FDA approval	Description of trial(s)	Primary end point	Duration of study
Asacol®	01/31/1992	Randomized, double blind, placebo controlled	Clinical remission via sigmoidoscopic improvement	6 weeks
		Randomized, double blind, placebo controlled	Maintenance of remission via sigmoidoscopic appearance	6 months
		Randomized, double blind, double dummy, controlled equivalence study vs sulfasalazine	Maintenance of remission via sigmoidoscopic appearance (Asacol was nonsignificantly inferior to sulfasalazine)	6 months
Pentasa®	05/10/1993	Randomized, double blind, placebo controlled	Induction of clinical remission, combination of physician global assessment and sigmoidoscopic index	8 weeks
Lialda®	01/16/2007	Randomized, double blind, placebo controlled	Clinical remission defined as UCDAI score ≤1, with score 0 for rectal bleeding and stool frequency and sigmoidoscopy score reduction ≥1 point from baseline	8 weeks
Apriso®	10/31/2008	Randomized, double blind, placebo controlled	Maintenance of remission. Relapse free at end of study defined as a Sutherland Disease Activity Index rectal bleeding subscale score ≥1 and mucosal appearance subscale score ≥2. Symptoms of UC flare or restarting UC medications also counted as relapse	6 months

UC: Ulcerative colitis; UCDAI: Ulcerative Colitis Disease Activity Index.

Data taken from [84].