FDA Approves Ferring's CLENPIQ (Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid) Oral Solution for Colonoscopy Prep
New Ready-to-Drink Low-Volume Colonoscopy Prep in a Premixed Liquid Solution
PARSIPPANY, N.J., Nov. 29, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals approval to market CLENPIQ™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy. With availability planned in Q1 2018, CLENPIQ will be the only FDA-approved prescription colonoscopy prep that comes "ready-to-drink".
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
"Successful bowel prep is critical for gastroenterologists to clearly see the inside of the colon during a colonoscopy. The sheer volume of a prescribed bowel prep solution can be a barrier for some patients to adequately complete their prep regimen, leading to suboptimal visualization of the colon," said Dr. Edward Brettholz, Clinical Assistant Professor of Medicine, NYU School of Medicine. "Having a ready-to-drink, low volume colonoscopy prep in a pre-mixed oral solution is an excellent start to prepare patients for this important procedure to help detect and prevent colorectal cancer."
"We are delighted to add CLENPIQ to our gastroenterology portfolio," said Paul Navarre, CEO, Ferring Holding Inc. "We expect that a ready-to-drink bowel preparation will aid physicians in their efforts to encourage colonoscopies among a patient population for whom various public health initiatives have called for increased screening."
Important Safety Information
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 800.FDA.1088.
For full prescribing information, please visit: www.CLENPIQ.com
About Ferring Pharmaceuticals Inc.
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.
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.
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SOURCE Ferring Pharmaceuticals Inc.