PARSIPPANY, N.J., Feb. 12, 2018 /PRNewswire/ -- Ferring Pharmaceuticals Inc. announced today that CLENPIQ™ (sodium
Colorectal cancer is the third most common cancer and second leading cause of cancer death in the United States.1 Colonoscopies can help reduce the incidence of colorectal cancer and deaths associated with this disease.2,3,4
"A safe, effective and well-tolerated bowel prep is an important step towards a successful colonoscopy," said Dr. Jonathan Cohen, Clinical Professor of Medicine, NYU Langone Health. "Patients now have the option of a ready-to-drink, low volume bowel prep."
"At Ferring, we have a long-standing commitment to develop and advance therapies in gastroenterology," said Paul Navarre, CEO, Ferring Inc. "Now with the launch of the first ready-to-drink bowel prep, we are offering physicians and patients an enhanced treatment option and strengthening the foundation of our growing U.S. gastroenterology portfolio."
About CLENPIQCLENPIQ is a ready-to-drink, low volume bowel prep with cranberry-flavor. It is a dual-acting, combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid, which forms magnesium citrate, an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.5
CLENPIQ has established efficacy and safety based on clinical trials with another oral formulation of sodium picosulfate, magnesium oxide and anhydrous citric acid. The efficacy of the split-dose regimen was evaluated for non-inferiority against a day-before comparator (2L PEG with electrolytes plus 2X5 mg bisacodyl tablets). In the split dose trial supporting Clenpiq approval, 84% of patients achieved successful cleansing of the overall colon (primary endpoint) and 90% achieved successful cleansing of the ascending colon (secondary endpoint).5,6 The primary efficacy endpoint was the proportion of patients with successful cleansing of the overall colon defined as "excellent" or "good" using the Aronchick scale, which is scored before washing of the colon. 6 A secondary endpoint was the proportion of patients with successful cleansing of the ascending colon defined as 'excellent", "good" or "fair" using the Ottawa scale.6 The most commonly observed (? 1% of patients) adverse reactions in that study were nausea (3%), headache (2%) and vomiting (1%).5
Important Safety Information
You are encouraged to report negative side effects of prescription drugs to FDA. Visit http://www.FDA.gov/medwatch, or call 800.FDA.1088.
For full prescribing information, please visit: www.CLENPIQ.com
About Ferring Pharmaceuticals Inc.Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women's health, urology, gastroenterology, endocrinology and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com or www.CLENPIQ.com
Ferring acquired global rights (excluding Korea) to the stable liquid formulation used in CLENPIQ from Pharmbio Korea co., Ltd.
FERRING, the FERRING PHARMACEUTICALS logo, and CLENPIQ are trademarks of Ferring B.V.
Ana FullmerAna.email@example.com 202-530-4662
References:1 U.S. Center for Disease Control and Prevention. Colorectal Cancer Statistics. https://www.cdc.gov/cancer/colorectal/statistics/index.htm. Last updated: March 23, 2017.2 American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer Society; 2017.3 Brenner, et al. Potential for Colorectal Cancer Prevention of Sigmoidoscopy Versus Colonoscopy: Population-Based Case Control Study. Cancer Epidemiol Biomarkers Prev. 2007; 16:494-499. 4 Khai, et al. Effect of Screening Colonoscopy on Colorectal Cancer Incidence and Mortality. Clinical Gastroenterology and Hepatology. 2009; 7:770–775.5 CLENPIQ™ [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.6 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(1):132-141.
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SOURCE Ferring Pharmaceuticals Inc.
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