FDA approves low-volume colon-cleansing drug for colonoscopy

July 17, 2012|By Thomas H. Maugh II

The FDA has approved a new drug that should make preparation for colonoscopy… (National Library of Medicine…)

The Food and Drug Administration on Tuesday approved a new drug for cleansing the colon before colonoscopy exams that requires drinking only 10 ounces of the product, not the 2 liters required with some current products such as Go Lightly. The patient must drink other fluids as well, but that can be water, soda or other pleasant-tasting liquids.

The new cleansing agent, called Prepopik, is expected to be marketed by October, according to the manufacturer, Ferring Pharmaceuticals Inc. of Parsippany, N.J.

Colorectal cancer is the third-most common type of cancer in the United States and the second leading cause of cancer deaths. More than 143,000 new cases will be diagnosed this year and almost 52,000 people will die from it.

Sadly, the majority of those deaths could be prevented by early detection and treatment. Routine colonoscopy is very effective at identifying polyps that are precursors of cancer, but many people are reluctant to undergo the procedure.

The colonoscopy itself is generally not a problem because the patient is sedated, but the preparation is unpleasant, requiring consumption of large amounts of vile-tasting fluids that purge the intenstinal tract and the better part of a day spent sitting on the "throne." The new drug could minimize at least one of those problems.

Prepopik is a combination of sodium picosulfate, magnesium oxide and anhydrous citric acid with an orange flavoring. It is taken in two doses: either both doses the day before the colonoscopy or one dose the day before and one the morning of the exam.

In two large clinical trials, the drug was compared to conventional preparation. The two doses given the day before were as effective at cleansing the bowel as the conventional procedure, while the doses given the night before and the morning of the procedure were more effective. Cleaning the bowel thoroughly is important because it removes materials that can interfere with identifying polyps.

Side effects of the drug were nausea, headaches and vomiting and the incidence was lower than the incidence for conventional preparation.

Prepopik was first approved outside the United States in 1980 and has been used by 28.8 million patients around the world, according to the company.

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