February 12, 2018
Ferring’s CLENPIQ™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep Now Available
First and only FDA-Approved, Ready-to-Drink Low-Volume Bowel Prep
Parsippany, NJ – February 12, 2018 – Ferring Pharmaceuticals Inc. announced today that CLENPIQ™
(sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy is now available by prescription in the United States. Approved by the U.S. Food and Drug Administration (FDA) in November 2017, CLENPIQ is the only FDA-approved prescription bowel 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
“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.”
CLENPIQ 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
• CLENPIQ oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in
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,
• 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 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.
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.
© 2018 Ferring B.V. 1/2018 CLEN/166/2018/US