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FDA Approves A Brand New Drug For Colonoscopy-Prepping

On July 16th of 2012, the United States FDA approved Prepopik (composed of sodium picosulfate, magnesium oxide as well as citric acid) to aid in the process of cleansing the colon of adults preparing for a colonoscopy.  A single dose of Prepopik comprises of 2 packets of powder which is soluble in cold water and meant to be taken at separate times.  It is recommended that patients take this medication the night before a colonoscopy and morning time during the day of the colonoscopy.  If this isn’t feasible, then patients should take Prepopik in the afternoon and the evening before the colonoscopy.

As a part of the regimen of Prepopik, patients taking this drug must consume additional fluids during before and after use.  Intake of fluids is important in reducing the risk of electrolyte and fluid imbalance.  The most common adverse side effects reported with adult patients prescribed Prepopik includes vomiting, nausea, and headache.

According Dr. Victoria Kusiak, M.D., who’s deputy director for the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, “The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences”.  Furthermore she goes on to say, “Today’s approval provides a new treatment option for patients and doctors to consider.”

The efficacy and safety of Prepopik was established in 2 clinical studies with about 1,200 adult patients who were undergoing a colonoscopy.  Patients were assigned randomly to take either the Prepopik Split-Dose regimen, the Day-Before regimen, or a controlled preparation which consisted of polyethylene glycol plus electrolytes (PEG+E) solution and two 5-mg bisacodyl tablets.

The study was designed to measure the exact amount of patients whose colons were cleansed before a colonoscopy successfully.  Prepopik was about as effective as the control preparation when it came to cleansing the colon.  In the study where a patient was administered the Split-Dose regimen, it was superior compared to the control preparation.  In this regimen, Prepopik was administered usually on the day before the scheduled colonoscopy and also on the morning of the colonoscopy.  The control preparation was given to the designated patients entirely on the day before the colonoscopy.

Ferring Pharmaceuticals, based in Parsippany, New Jersey, must conduct studies to gauge if the drug can be used safely and effectively in children as a condition of its approval.