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FDA Approves New Bowel Prep Product for Colonoscopy


 

Another option for colon cleansing before colonoscopy is available, with the approval of a powder-based product that is dissolved in water and administered in two doses.

The product will be marketed as Prepopik by Ferring Pharmaceuticals, and will be available in October 2012, the company statement said.

The product is a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide with anhydrous citric acid, which form magnesium citrate, an osmotic laxative. The patient receives two packets of powder to be dissolved in cold water and consumed at two different times, according to the Food and Drug Administration statement announcing the approval on July 17.

There are two options for when the product can be consumed in relation to the procedure time, according to the prescribing information. The "split-dose" method is preferred, and this involves taking the first dose the night before the colonoscopy and the second in the morning before the colonoscopy. Another option is to take the two doses in the afternoon and evening of the day before the procedure, with 6 hours between doses, known as the "day-before" method, the statement said. Additional clear fluids should be consumed after both dosing regimens.

Approval was based on two randomized clinical studies of about 1,200 adults undergoing a colonoscopy, who were assigned to the split-dose Prepopik regimen, the day-before Prepopik regimen, or a control regimen of polyethylene glycol plus electrolytes (PEG+E) with two 5-mg bisacodyl tablets taken the day before the colonoscopy.

In both studies, the use of Prepopik was as effective as the control preparation in cleansing the colon, but in the study that evaluated the split-dose regimen, this regimen was superior to the control preparation, the statement said.

The most common adverse events associated with Prepopik were nausea, vomiting, and headache. With split-dose Prepopik, the rates of nausea, vomiting, and headache were 2.6%, 1%, and 1.6%, respectively, compared with 3.7%, 3.4%, and 1.7% for the control regimen. With day-before Prepopik, rates of nausea, vomiting, and headache were 3%, 1.4%, and 2.7%, compared with 4.3%, 2%, and 1.7% for the control regimen.

On the day of colonoscopy, the rates of abnormal electrolyte shifts were numerically higher among those who used Prepopik, but the shifts were "transient in nature," according to the prescribing information.

In the statement, Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, "The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences."

As a condition of approval, Ferring is required to conduct studies to determine if the product is safe and effective in children.

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