The FDA has approved Prepopik, a powder mixture of sodium picosulfate, magnesium oxide, and citric acid, as a colonoscopy prep.
The new prep is a low volume drink that consists of two 5 ounces of water and two packets of laxative chemicals that need to be mixed together. In two clinical trials it was as effective as polyethylene glycol plus electrolytes (PEG+E) solution and two 5-milligram bisacodyl tablets. (HalfLytely for Bowel Preparation for Colonoscopy) and (HalfLytely for Bowel Preparation for Colonoscopy – Split Dose)
The new Prepopik reduces the amount of treatment liquid the patient must drink from a little over 2 quarts (67 ounces) to 10 ounces. However, after drinking the prep, patients need to drink lots of water or clear liquids — five 8 ounce glasses after the first Prepopik dose and three 8 ounce glasses after the second. The taste and volume of the colonoscopy preparation has been a major roadblock for people getting colonoscopy screening for colon cancer. Prepopik lowers the volume significantly and improves the taste.
For gastroenterologists, it is important that the colon is completely cleaned so they can see the entire surface and not miss small or flat polyps. Colon cleansing was the primary objective of both studies. In one, the split dose prep, where the prep was given in a split dose, half the night before the colonoscopy, half the morning of the procedure, Prepopik actually beat the control treatment in how well the colon was cleaned. When both doses were given the day before the colonoscopy, both preps were equal in getting the colon clean.
Because it cleans the colon more effectively, gastroenterologists are now recommending split dosing for their patients no matter what prep is being used.
Prepopik is not safe for all people. Those with kidney problems should not use it. There is no evidence that it is safe for pregnant women, so they shouldn’t take it unless there is a clear need.
It is not okayed for children right now but the FDA is requiring Ferring Pharmaceticals to conduct studies to see if Prepopik is safe and effective in children as part of the approval.
Although approved now, it is not expected to be available on the market until October 2.