Prepopik Approved for Colonoscopy Prep
PREPOPIK (sodium picosulfate,magnesium oxide,anhydrous citric acid) 10mg/3.5g/12g packets by Ferring
Ferring Pharmaceuticals announced that the FDA has approved Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid powder) for oral solution indicated for cleansing of the colon as a preparation for colonoscopy in adults. Prepopik, a stimulant and osmotic laxative, is the lowest volume (10oz) active ingredient colon preparation that has been FDA-approved.
The FDA approval is based on data from two Phase III non-inferiority studies in which Prepopik was compared to 2L PEG+E plus two Bisacodyl 5mg tablets. In both studies, Prepopik achieved the primary endpoint (successful colon cleansing based on the Aronchick Scale), demonstrating non-inferiority to the comparator [Study 1: 84.2% vs. 74.4%; Study 2: 83.0% vs. 79.7%].
Prepopik will be available as two powder packets, each containing 10mg sodium picosulfate, 3.5g magnesium oxide, and 12g anhydrous citric acid.
For more information call (888) FERRING or visit www.prepopik.com.