Ferring to Present Clinical Data on Efficacy and Safety of CLENPIQ(TM) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep at Digestive Disease Week
PARSIPPANY, N.J., June 5, 2018 /PRNewswire/ -- Today at Digestive Disease Week® (DDW), in Washington, D.C., Ferring Pharmaceuticals Inc. will present clinical trial data from 12:00-2:00 p.m. in Hall C of the Walter E. Washington Convention Center. In a poster session, Dr. Lawrence Hookey will share results from the study, titled "A Randomized, Assessor-Blinded, Multicenter Study Demonstrates the Efficacy and Safety of a New Ready-to-Drink Low Volume Bowel Preparation Prior to Colonoscopy" (Poster # Tu2010).
The study evaluated the efficacy of a split-dose regimen of sodium picosulfate, magnesium oxide, and anhydrous citric acid in a ready-to-drink oral solution (SPMC oral solution) compared to split-dose sodium picosulfate, magnesium oxide, and citric acid powder which requires dilution and mixing (P/MC powder) in adult patients undergoing a colonoscopy. In the study, the primary endpoint for efficacy was overall colon cleansing assessed by the Aronchick scale and the secondary endpoint of cleansing the ascending (right) colon was assessed using the Boston Bowel Preparation scale. The authors reported that SPMC oral solution met both its primary and secondary efficacy endpoints (non-inferiority to the comparator). The adverse event profiles of SPMC oral solution and P/MC powder were comparable in this study.
"Many of my patients see colonoscopies as an ordeal they must endure for their overall health," said Lawrence Hookey, MD, Medical Director of Endoscopy, Chair of Division of Gastroenterology, Associate Professor of Medicine, Queen's University, Kingston, Ontario. "An effective bowel preparation is essential for a successful screening colonoscopy. The data from this study confirm the efficacy of a ready-to-drink treatment option that can help adult patients prepare for their colonoscopy."
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 )
"Ferring is committed to advancing therapies in gastroenterology," said Joan-Carles Arce, Chief Scientific Officer, Ferring USA. "This study contributes to the body of evidence demonstrating the efficacy and safety of this ready-to-drink, low volume bowel prep."
CLENPIQ(TM) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy was approved by the U.S. Food and Drug Administration (FDA) in November 2017 and is currently available in the United States. CLENPIQ is the first and only FDA-approved prescription bowel prep that comes "ready-to-drink".
About CLENPIQ
CLENPIQ is the first and only FDA-approved, ready-to-drink, low volume bowel prep. 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)
Important Safety Information
-- CLENPIQ is contraindicated in the following conditions: patients with
severe renal impairment (creatinine clearance less than 30mL/minute),
gastrointestinal obstruction or ileus, bowel perforation, toxic colitis
or toxic megacolon, gastric retention, or in patients with a known
hypersensitivity to any of the ingredients in CLENPIQ.
-- Patients should be advised to hydrate adequately (before, during and
after use of CLENPIQ), and post-colonoscopy lab tests should be
considered if a patient develops significant vomiting or signs of
dehydration, including orthostatic hypotension, after taking CLENPIQ.
Patients with electrolyte abnormalities should have them corrected
before treatment. Use caution when prescribing CLENPIQ for patients that
have conditions or are using medications that increase the risk for
fluid and electrolyte abnormalities.
-- Use caution in patients who have conditions, or are taking concomitant
medications that increase the risk for seizures, such as those taking
medications that lower the seizure threshold, patients withdrawing from
alcohol or benzodiazepines or patients with known or suspected
hyponatremia.
-- Use caution in patients with impaired renal function or taking
medications that may affect renal function, as well as patients at
increased risk of arrhythmias, including those patients with a history
of prolonged QT, recent myocardial infarction, unstable angina,
congestive heart failure, or cardiomyopathy.
-- 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 CLENPIQ may increase this risk.
-- Use with caution in patients with severe active ulcerative colitis.
-- Use with caution in patients with impaired gag reflex as they may be at
risk for regurgitation or aspiration during administration of CLENPIQ.
-- The safety of CLENPIQ has been established from adequate well controlled
trials of another oral formulation of sodium picosulfate, magnesium
oxide and anhydrous citric acid. The most common adverse reactions in
those trials were nausea, headache, and vomiting.
-- CLENPIQ can reduce the absorption of co-administered drugs. Do not take
oral medications within one hour of starting CLENPIQ. Administer
tetracycline and fluoroquinolone antibiotics, iron, digoxin,
chlorpromazine and penicillamine, at least 2 hours before and not less
than 6 hours after administration of CLENPIQ to avoid chelation with
magnesium.
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
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
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.
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 19, 2018.
(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(TM) [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
SOURCE Ferring Pharmaceuticals Inc.
