FDA Approves Low-Volume Bowel Preparation

Nancy A. Melville


July 18, 2012

July 18, 2012 — The US Food and Drug Administration (FDA) has approved Prepopik (Ferring Pharmaceuticals), a new bowel preparation for cleansing the colon before colonoscopy.

When it becomes available, the dual-acting stimulant and osmotic laxative will be notable for its low volume, representing "the lowest volume active ingredient colon preparation available — with 10 ounces of prep solution," according to a Ferring Pharmaceuticals news release.

The preparation consists of 2 packets of sodium picosulfate, magnesium oxide, and citric acid. In a split-dose regimen, patients dissolve the first packet of powder into water and drink the orange-flavored solution the night before a scheduled colonoscopy, and then do the same for the second packet the morning of the procedure.

If that split-dose regimen cannot be performed, patients may also take the drug as a day-before regimen in the afternoon and evening before a colonoscopy.

Patients are also advised to drink additional fluids during and after use of the preparation to reduce the risk for fluid and electrolyte imbalance.

The FDA's approval was based on 2 phase 3 trials involving about 1200 adult patients who were scheduled for colonoscopies. The patients were randomly assigned to either the split-dose or day-before regimen or to a control preparation consisting of a polyethylene glycol plus electrolytes solution and two 5-mg bisacodyl tablets, administered entirely the day before the colonoscopy.

In both studies, Prepopik achieved the primary endpoint of successfully cleansing patients' colons based on the Aronchick Scale and demonstrated noninferiority to the control preparation.

The most common adverse effects related to Prepopik in study 1, involving a split-dose treatment group (n = 305) compared with the control group (n = 298), were nausea (2.6% vs 3.7%), headache (1.6% vs 1.7%), and vomiting (1.0% vs 3.4%).

In study 2, involving a day-before dose of Prepopik (n = 296) vs the comparator (n = 302), the adverse effects were similar, including nausea (3.0% vs 4.3%), headache (2.7% vs 1.7%), and vomiting (1.4% vs 2.0%).

"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 the FDA's Center for Drug Evaluation and Research, in an FDA news release. "Today's approval provides a new treatment option for patients and doctors to consider."

According to Ronald P. Fogel, MD, a gastroenterologist from the Digestive Health Center of Michigan in Chesterfield, the idea of a small-volume solution is an important selling point for a bowel preparation.

"A major advantage of Prepopik is the smaller volume," he told Medscape Medical News. "Patients dread taking the large-volume cleansing preparations, and for some it is a deterrent for having the procedure."

The market is open for a product that helps alleviate the discomfort of a large-volume preparation, he added.

"The oral phospho-soda prep that was removed from the market for safety reasons was very popular with patients," Dr. Fogel said. "Prepopik has the potential to fill a niche in the cleansing procedure market because of the relatively small volume ingested.

"Any changes that increase the use of screening colonoscopy and allow for high-quality colonoscopy [are] a huge benefit to our patients."

Gastroenterologist Michael L. Weinstein, MD, underscored the importance of the bowel preparation in a successful colonoscopy.

"Less volume means the patient is more likely to be able to complete it," said Dr. Weinstein, from Capital Digestive Care in Bethesda, Maryland.

"I tell patients the most unpleasant part of a colonoscopy is the prep, but the most important part is the prep," he said.

"If the colon is not clean, it doesn't matter how good the colonoscopist is at making the procedure comfortable or easy; if we can't see, the procedure may be a failure, and that's a lot of effort to have to waste."

He added that the price of any new colon preparation is also a big factor to consider.

"I always worry that new prescription, proprietary brand preps are going to expensive — $100 or more, whereas the older gallon preps can be $20 or less," Dr. Weinstein said.

"Depending on their insurance, some patients may only have to pay the $30 to $45 copay, but for others, that's $100 or more out-of-pocket — for something that's literally going to be flushed down the toilet."

In a statement to Medscape Medical News, Andrew Zanga, business unit head of US gastroenterology at Ferring Pharmaceuticals, said pricing for Prepopik has not yet been determined.

"We are planning to have the product available for retail distribution in October," Zanga said. "We will determine the price point at that time, taking into consideration the latest market factors and competitive prices."

Dr. Fogel and Dr. Weinstein have disclosed no relevant financial relationships.


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