News & Events
FDA NEWS RELEASE
For Immediate Release: July 17, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves new colon-cleansing drug for colonoscopy prep
On July 16, the U.S. Food and Drug Administration approved Prepopik (sodium picosulfate, magnesium oxide and citric acid) to help cleanse the colon in adults preparing for colonoscopy.
One dose of Prepopik consists of two packets of powder, each dissolved in cold water and taken at separate times. Patients should take Prepopik the night before colonoscopy and the morning of colonoscopy (Split-Dose regimen). If this is not possible, patients may take Prepopik in the afternoon and evening before the colonoscopy (Day-Before regimen).
As part of this colon-cleansing regimen, 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. The most common side effects reported in adult patients taking Prepopik include nausea, headache and vomiting.
“The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences,” says Victoria Kusiak, M.D., 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.”
The safety and effectiveness of Prepopik were established in two clinical studies with about 1,200 adult patients scheduled to have a colonoscopy. Patients were randomly assigned to take the Prepopik 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.
The studies were designed to measure the number of patients whose colons were cleansed successfully. In both studies, Prepopik was as effective as the control preparation in cleansing the colon. In the study in which Prepopik was administered in the Split-Dose regimen, it was superior to the control preparation in cleansing the colon. In the Split-Dose regimen, Prepopik is administered on the day before colonoscopy and on the morning of colonoscopy. The control preparation of the study was administered entirely the day before colonoscopy.
As a condition of approval, Prepopik’s manufacturer Ferring Pharmaceuticals must conduct studies to determine if the drug can be used safely and effectively in children.
Ferring Pharmaceuticals is based in Parsippany, N.J.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
#
Read our Blog: FDA Voice
Visit the FDA on Facebook 
, Flickr , YouTube , and Twitter
RSS Feed for FDA News Releases
