In support of NDA 22-301, submitted

In support of NDA 22-301, submitted were final study reports of 11 phase 1/2 clinical trials, three phase 3 trials (MPPK 3003, MPPK 3004, MPPK3005) and one in vitro study for drug interaction. Of 11 submitted studies, three of them were most relevant: a relative BA study evaluating mesalamine granules BID and QD and Asacol BID (MPPK 1001), a food effect study (MPPK 1002) and single dose and multiple dose PK study (MPPK 1003). All other studies were supportive and conducted using different formulations from the to-be-marketed formulation. Most of the supportive studies were relative BA or food effect study for formulations in development and one PK study were conducted in pediatric patients with inflanmatory bowel disease.