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Agency approves colonoscopy prep regimen
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The FDA recently approved the use of Prepopik for colon cleansing prior to colonoscopy.
The treatment, developed by Ferring Pharmaceuticals, consists of sodium picosulfate, magnesium oxide and citric acid powder packets that are dissolved in cold water. Patients take the regimen 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 two clinical studies designed to evaluate 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. Day-before Prepopik was found to be equally effective to the control solution, and the split-dose regimen was found to be a more effective cleanser than the control, according to a press release. The approval was conditional upon Ferring conducting studies to evaluate 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. “[This] approval provides a new treatment option for patients and doctors to consider.”