FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy

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The FDA has approved sodium picosulfate, magnesium oxide, and citric acid (Prepopik) to help cleanse the colon in adults preparing for colonoscopy, Ferring Pharmaceuticals announced. The new solution is a low-volume, dual-acting stimulant and osmotic laxative.

The FDA approval is based on data from two phase III studies, in which the regimen was as effective or superior to the control population in cleansing the colon. The most common side effects reported in adult patients taking the solution were nausea, headache, and vomiting.

One dose of the solution consists of two packets of powder, each dissolved in cold water and taken at separate times. Patients should take the product the night before colonoscopy and the morning of colonoscopy (split-dose regimen). If this is not possible, patients may take it in the afternoon and evening before the colonoscopy (day-before regimen).

As a condition of approval, studies must be conducted to determine if the drug can be used safely and effectively in children. ■




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