Nov 29, 2017   SOURCE: PR NewsWire

FDA Approves Ferring's CLENPIQ(TM) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep

PARSIPPANY, N.J., Nov. 29, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market CLENPIQ(TM) (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."

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.(5)

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.

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 Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive 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.

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Contact:
Ana Fullmer
Ana.fullmer@bm.com
202-530-4662

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 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(TM) [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.

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SOURCE Ferring Pharmaceuticals Inc.