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FDA approves Prepopik as colon cleanser for colonoscopy prep
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The FDA recently approved the use of Prepopik for colon cleansing prior to colonoscopy, according to a press release.
The treatment (Ferring Pharmaceuticals) consists of sodium picosulfate, magnesium oxide and citric acid powder packets that are dissolved in cold water and taken once the night before and once the morning of colonoscopy, or on the afternoon and evening before if the split-dose regimen is not possible. Additional fluid intake is necessary during and after use. Common side effects in adult patients included nausea, headache and vomiting.
Prepopik was approved following the results of two clinical studies evaluating its safety and effectiveness. Participants (n=1,201) randomly received split- or day-before doses of Prepopik or a control preparation of polyethylene glycol with electrolytes and two 5-mg bisacodyl tablets. Prepopik was found equally effective to the control solution, except for the split-dose regimen, which was considered a more effective cleanser than the control, according to the release. The approval was conditional upon Ferring conducting studies evaluating the safety and efficacy of Prepopik in children.
“The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences,” Victoria Kusiak, MD, deputy director of the FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation III, said in the release. “Today’s approval provides a new treatment option for patients and doctors to consider.”