Attapulgite data from Mexico and Jamaica can be analyzed together, FDA tells NDMA.
This article was originally published in The Tan Sheet
Executive Summary
ATTAPULGITE MEXICO/JAMAICA DATA CAN BE COMBINED FOR ANALYSES, FDA said at a July 17 "feedback" meeting on the antidiarrheal, held in Rockville, Md. The Nonprescription Drug Manufacturers Association's Attapulgite Task Group asked FDA representatives whether data from the two attapulgite clinical study sites -- Mexico and Jamaica -- can be combined for primary and secondary analyses. The multicenter approach would allow NDMA to complete the placebo-controlled efficacy study for acute nonspecific diarrhea in a shorter period of time.