PARSIPPANY, N.J., Oct. 22, 2012 /PRNewswire/ -- Ferring Pharmaceuticals Inc. has announced the presentation at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting of study results from the SEE CLEAR (Safety and Efficacy of Dual-Action PREPOPIK: An Evaluation of Colon Cleansing in Day-Before And Split-Dose Regimens) I and II pivotal studies for PREPOPIK for oral solution.
In both studies, PREPOPIK for oral solution demonstrated effective cleansing of the colon as a preparation for colonoscopy in adults. PREPOPIK is the lowest volume active prep solution, and is now available by prescription in U.S. pharmacies.
Results from SEE CLEAR I and II studies will be presented Tuesday, October 23 during ACG at The Venetian Hotel in Las Vegas [SEE CLEAR I: oral presentation, 8:30 8:40 a.m. PT, abstract #10123; SEE CLEAR II: poster presentation, 10:30 a.m. 4 p.m. PT, Exhibit Hall B, poster #P1581, abstract #10123].1,2,3
Two validated scoring scales were used in the SEE CLEAR clinical program: the Aronchick scale (for the primary endpoint) and the Ottawa scale (for the main secondary endpoint and additional analyses).
The non-inferiority studies compared PREPOPIK to 2L PEG+E plus 2x 5-mg bisacodyl tablets. In both studies, PREPOPIK achieved the primary endpoint (successful colon cleansing), demonstrating non-inferiority to the comparator [ITT, SEE CLEAR I: 84.2% vs. 74.4%, 1-Sided 97.5% CI (3.4%); ITT, SEE CLEAR II: 83.0% vs. 79.7%, 1-Sided 97.5% CI (-2.9%)].1,2
In the SEE CLEAR I split-dose study, PREPOPIK also demonstrated statistical superiority to the comparator in two pre-specified analyses, of the primary endpoint (overall successful colon cleansing) and main secondary endpoint (successful ascending colon cleansing), [ITT, SEE CLEAR I: 89.5% vs. 78.8%, 1-Sided 97.5% CI (4.9%)].1
Analysis of the combined datasets demonstrated a greater proportion of patients with successful colon cleansing in patients >/= 65 years old in the PREPOPIK group (81.1%) than in the comparator group (70.9%), with similar overall incidence of treatment-emergent adverse events.3
The most common (>1%) adverse reactions in SEE CLEAR I possibly or probably related to PREPOPIK (n=305) versus the study comparator (n=298) were nausea (2.6% vs. 3.7%), headache (1.6% vs. 1.7%) and vomiting (1.0% vs. 3.4%).1 The most common (>1%) adverse reactions in SEE CLEAR II possibly or probably related to PREPOPIK (n=296) versus the comparator (n=302) were nausea (3.0% vs. 4.3%), headache (2.7% vs. 1.7%) and vomiting (1.4% vs. 2.0%).1,2,3
Colonoscopies have been shown to help reduce the incidence of colon cancer and deaths associated with the disease.4,5 Over the last decade, public health initiatives have helped drive up the rate of screenings, yet the current rates still fall short of public health targets set forth.5 Concurrently, the rate of adequate prepping for screenings, which is associated with colonoscopy effectiveness, has changed little over the last 10 years.6,7
About The SEE CLEAR I and II Studies
The randomized, investigator-blinded, active-controlled, multicenter SEE CLEAR I and II studies were conducted in the U.S. and evaluated the colon cleansing efficacy of PREPOPIK for non-inferiority against a comparator in patients scheduled to have an elective colonoscopy. Results showed that PREPOPIK was effective in achieving successful colon cleansing for adequate colonoscopy visualization in patients using either a split-dose (SEE CLEAR I) or day-before dose (SEE CLEAR II).1,2
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.
PREPOPIK was approved by the U.S. Food and Drug Administration (FDA) 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 U.S.
PREPOPIK is an orange-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.3 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. Split-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.8
Approved since 1980 outside of the U.S., PREPOPIK has been used by approximately 28.8 million patients globally based on post-marketing experience.9 PREPOPIK is available in Canada (marketed under the name PICO-SALAX®), U.K. (marketed under the name PICOLAX®) and other countries (marketed under the name PICOPREP®).
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.
(c) 2012 Ferring B.V.
PREPOPIK is a trademark of Ferring B.V.
- Rex, DK, et al. "Split-Dose Administration of a Novel, Dual-Action, Low-Volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR I Study," abstract #10123. Presented at the American College of Gastroenterology Annual Scientific Meeting, Oct. 23, 2012, Las Vegas.
- Katz, PO, et al. "Day-Before Administration of a Novel, Dual-Action, Low-Volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR II Study," abstract #10123. Presented at the American College of Gastroenterology Annual Scientific Meeting, Oct. 23, 2012, Las Vegas.
- PREPOPIK [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; July 2012.
- Siegel, RS, et al. CA Cancer J Clin, 2012;62:118-128.
- American Cancer Society. Colorectal Cancer Facts and Figures 2011-2013. http://www.cancer.org/Research/CancerFactsFigures/ColorectalCancerFactsFigures/colorectal-cancer-facts-figures-2011-2013-page. Accessed June 25, 2012.
- Harewood GC, Sharma VK, de Garmo P, Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia, Gastrointest Endosc, 2003; 58: 76-9.
- Lebwohl, B., F. Kastrinos, M. Glick, et al., The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc, 2011. 73(6): p. 1207-14.
- Rex, D.K. et al. American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2008. Am J Gastroenterol.2009; 104:739 750; doi: 10.1038/ajg.2009.104; published online 24 February 2009.
- Ferring Pharmaceuticals, DATA ON FILE.
SOURCE Ferring Pharmaceuticals Inc.