August 1, 2012

FDA Approves Lower Volume Bowel Prep for Colonoscopies

Parsippany, NJ—Patients preparing for a colonoscopy have a new, lower-volume option for bowel cleansing, but it is important that pharmacists emphasize the need for additional fluid intake when using it.

The FDA approved sodium picosulfate, magnesium oxide, and citric acid, marketed as Prepopik by Ferring Pharmaceuticals Inc., to help prepare for the colon cancer screening procedure.

In a press release announcing the approval, Ferring noted that, when commercially available, Prepopik is the lowest volume active ingredient colon preparation available, with 10 ounces of prep solution.

"The choice of a bowel cleansing regimen for colonoscopy should be based on a patient's health and personal preferences," said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "Today's approval provides a new treatment option for patients and doctors to consider."

Ferring noted in its press release that the high volume of other prep solutions can prevent patients from adequately preparing, making it hard for their physician to screen the colon.

A dose of Prepopik includes of two packets of powder, each dissolved in cold water and taken at separate times. Based on their circumstances, patients have the option of a "split-dose regimen," with one dose the night before the colonoscopy and another dose the morning of the procedure, or a "day-before regimen" where they use Prepopik the afternoon and the evening before the colonoscopy.

The FDA cautioned that "patients taking Prepopik must consume additional fluids during and after use. Additional fluid intake is also important to reduce the risk of fluid and electrolyte imbalance." Side effects can include nausea, headache, and vomiting.

Two clinical studies, including about 1,200 adult patients scheduled to have a colonoscopy, were used to establish the safety and effectiveness of Prepopik. For the research, participants were randomly assigned to take the "split-dose regimen, the day-before regimen, or a control preparation consisting of polyethylene glycol plus electrolytes (PEG+E) solution and two 5-milligram bisacodyl tablets."

In both studies, Prepopik was as effective as the control preparation in cleansing the colon, and it was actually more effective when the split-dose regimen was used.

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

U.S. Pharmacist Social Connect