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United States : FDA approves Ferrings CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for colonoscopy prep.

The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. 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.1Colonoscopies can help reduce the incidence of colorectal cancer and deaths associated with this disease.

"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.

About CLENPIQ

CLENPIQ is a ready-to-drink cranberry-flavored, 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.

Important Safety Information

CLENPIQ is contraindicated in the following conditions: patients with severe renal impairment (creatnine 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 may 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 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.

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Publication:Mena Report
Date:Dec 4, 2017
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