October 7, 2014
FERRING PHARMACEUTICALS INC. RECEIVES FDA APPROVAL FOR NEW CRANBERRY FLAVOR OF PREPOPIK® (SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID)
PREPOPIK a prescription bowel prep for colonoscopy offers the lowest volume of active prep solution — only 10 ounces
PARSIPPANY, N.J., Oct. 7, 2014 /PRNewswire/ – Colonoscopy is an important and widely used screening tool for colorectal cancer, but for many patients the bowel-preparation process is more uncomfortable than the procedure itself. To offer an alternative choice in bowel preparation, Ferring Pharmaceuticals Inc. will introduce a new cranberry flavor option of PREPOPIK in January 2015. The cranberry flavor of PREPOPIK was approved by the U.S. Food and Drug Administration (FDA) on August 22, 2014.
“Since our launch of orange-flavor PREPOPIK in 2012, Ferring has been committed to colon cancer screening and the importance of early detection through colonoscopy. Thorough colon cleansing is essential to a successful colonoscopy, and now with the approval of new cranberry flavor PREPOPIK, patients have two flavor choices, with the least amount of medicine to drink. Ferring is committed to providing effective pharmaceutical options for patients who are preparing for their colonoscopy procedure,” says Andrew Zanga, head of the U.S. Gastroenterology business unit at Ferring Pharmaceuticals Inc.
Indication and Important Safety Information
PREPOPIK® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
PREPOPIK is contraindicated in the following conditions: patients with severely reduced renal function, gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or in patients with a known allergy to any of the ingredients in PREPOPIK. Patients should be advised on the importance of adequate hydration, and post-colonoscopy lab tests should be considered if a patient develops significant vomiting or signs of dehydration after taking PREPOPIK. Patients with electrolyte abnormalities should have them corrected before treatment. Use caution when prescribing for patients who are at risk for seizures, or arrhythmias, including those patients with a history of prolonged QT, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy. Caution should also be used in patients with impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function, electrolyte imbalance and/or water retention. Oral medication administered within one hour of the start of administration of PREPOPIK solution may be flushed from the GI tract and the medication may not be absorbed. Prior or concomitant use of antibiotics with PREPOPIK may reduce its efficacy. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PREPOPIK to avoid chelation with magnesium. Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with PREPOPIK may increase this risk. PREPOPIK should not be used if gastrointestinal obstruction or perforation is suspected. Prepopik is not for direct ingestion. Each packet must be dissolved in 5 ounces of cold water and administered at separate times, in addition to additional clear fluids, according to the dosing regimen. In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common treatment-emergent adverse events (>1%) following PREPOPIK administration.
Please see Full Prescribing Information at http://www.prepopik.com/prepopik_prescribing_information.pdf
PREPOPIK was approved by the U.S. Food and Drug Administration on July 17, 2012, based on data from the pivotal SEE CLEAR I and II studies. The approval marks Ferring Gastroenterology’s first entry into the gastroenterology market in the United States.
PREPOPIK is an orange- or cranberry-flavored, dual-acting, stimulant and osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. With 10 ounces of prep solution, PREPOPIK is the lowest-volume prep solution for colon preparation available.
PREPOPIK is available in two dosing options. It can be given as the ACG-recommended split-dose taken in the evening before and on the morning of the procedure.1,2 Day-before dosing is an alternative regimen for patients for whom split dosing is inappropriate, accounting for colonoscopy scheduling, distance traveled, and other personal circumstances. 1,3Split dosing has been shown to improve cleansing quality given its greater proximity to procedure time and appears to have higher compliance due to better tolerability of the liquid volume. 1,2
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics, and urology. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com or www.PREPOPIK.com.
© 2014 Ferring B.V.
PREPOPIK® is a trademark of Ferring B.V.
1. PREPOPIK® [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; August 2014.
2. Rex DK, Katz PO, Bertiger G, et al. Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study. Gastrointest Endosc 2013; 78:132-41.
3. Katz PO, Rex DK, Epstein M, et al. A dual-action, low-volume bowel cleanser administered the day before colonoscopy: results from the SEE CLEAR II study. Am J Gastroenterol 2013;108:401-9.