Healthcare Industry News: U.S. Food and Drug Administration
News Release - February 12, 2018
Ferring's CLENPIQ(TM) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep Now AvailableFirst and only FDA-Approved, Ready-to-Drink Low-Volume Bowel Prep
PARSIPPANY, N.J., Feb. 12, 2018 -- (Healthcare Sales & Marketing Network) -- 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 adults.
- 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.
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.
Source: Ferring Pharmaceuticals
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