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.