Breaking News
February 18, 2018 - A Role for Budesonide in Autoimmune Hepatitis?
February 18, 2018 - Lupus patients exhibit altered cell proteins, a discovery with potential implications for diagnostics
February 18, 2018 - Muscle plays vital role in regulating heat loss from the hands
February 18, 2018 - High-tech brain scans can provide new way to define intelligence
February 18, 2018 - Study reveals the association between ultra-processed foods and cancer
February 18, 2018 - Prescription Opioid Use Tied to Higher Pneumonia Risk
February 18, 2018 - A non-invasive method to detect Alzheimer’s disease
February 18, 2018 - Deletion of specific enzyme leads to improvement in memory and cognitive functions
February 18, 2018 - Amyloid protein may be transmitted through neurosurgical instruments, study suggests
February 18, 2018 - Electric brain signals of males and females show differences
February 18, 2018 - American Heart Association commends McDonald’s for offering healthier menu in kids’ meals
February 18, 2018 - Parents Find Kids’ Weight Report Cards Hard to Swallow
February 18, 2018 - Does a Financial Conflict of Interest Ever Expire?
February 18, 2018 - Exercise can improve Alzheimer’s symptoms
February 18, 2018 - Scientists develop green chemistry method to improve pharmaceutical manufacturing efficiency
February 17, 2018 - ‘A Time Clock to a Tissue Clock’ for Acute Stroke Care
February 17, 2018 - Cancer Care Gets Personal | NIH News in Health
February 17, 2018 - Do more youth use or do youth use more?
February 17, 2018 - Eating faster linked to obesity
February 17, 2018 - Who’s Still Smoking? ACS Report Highlights Most Vulnerable Adults
February 17, 2018 - Study of smoking and genetics illuminates complexities of blood pressure
February 17, 2018 - Study reveals new link between bone cells and blood glucose level
February 17, 2018 - Children with reading challenges may have lower than expected binocular vision test results
February 17, 2018 - Mass Shootings Trigger Change for Emergency Medicine
February 17, 2018 - ECMO helps revive woman thought to be drowned
February 17, 2018 - Learning stress-reducing techniques may benefit people with epilepsy
February 17, 2018 - Shedding Pounds Before Weight-Loss Surgery a Smart Move
February 17, 2018 - FDA Approves New Cystic Fibrosis Drug Combo
February 17, 2018 - Augmented Reality helps surgeons to ‘see through’ tissue and reconnect blood vessels
February 17, 2018 - Emotional state affects operation of the entire brain instead of being restricted to specific regions
February 17, 2018 - Apalutamide Slows Metastasis in Prostate Cancer
February 17, 2018 - Kids’ well visits linked to lower appendicitis complications
February 17, 2018 - New NK cell-based immunotherapy effective against several types of leukemia
February 17, 2018 - Producing Super-Swelled Lyotropic Crystals for Drug Development
February 17, 2018 - Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis
February 17, 2018 - Molecular Imaging Flags Risk of AAA Rupture
February 17, 2018 - Researchers identify risk factors for sleep apnea during pregnancy
February 17, 2018 - More work required to find the right drug dosage for pediatric patients
February 17, 2018 - Factors ID’d That Predict RA Remission with Etanercept
February 17, 2018 - A handout or a hand up? How we judge others guides how we help others
February 17, 2018 - ACR receives grant to focus on projects that reduce health disparities
February 17, 2018 - Pimavanserin Might Be Safer Alternative to Ease Dementia Psychosis
February 17, 2018 - Risks of Lung Screening Seen Outweighing Benefits in Many with Smoking History
February 17, 2018 - The impact of Hurricane Harvey on pregnant moms
February 17, 2018 - Gene editing tool used to detect cancer
February 17, 2018 - Researchers detail molecular atlas of cells that form brain’s blood vessels
February 17, 2018 - TUM scientists observe formation of myelin sheaths around nerve fibers
February 17, 2018 - Worst Flu Season Yet? | Medpage Today
February 17, 2018 - Finding the root cause of bronchiolitis symptoms
February 17, 2018 - Climbing stairs reduces hypertension and strengthens muscles
February 17, 2018 - Nature paper unveils bacterial division
February 16, 2018 - Postoperative pain control following extensive pelvic exenteration
February 16, 2018 - Daré Bioscience, Inc. Enters into License and Collaboration Agreement for a Product with the Potential to Receive the First FDA Approval for Female Sexual Arousal Disorder
February 16, 2018 - Havana Embassy Staff: ‘Concussion Without Concussion’?
February 16, 2018 - Family impact of congenital Zika syndrome likely to last a lifetime
February 16, 2018 - STI Prevention Helped By Also Discussing Pot, Alcohol Use
February 16, 2018 - New method maps the dopamine system in Parkinson’s patients
February 16, 2018 - Monitoring the Environment of Aseptic Processes
February 16, 2018 - Study finds decline in number of clinical trials funded by NIH
February 16, 2018 - Scientists show connection between sugar chains and bone growth
February 16, 2018 - Researchers develop new method for producing personalized medicine
February 16, 2018 - Women exposed to cleaning products suffer decreased lung function, Study finds
February 16, 2018 - Stem cell vaccine helps protect mice against numerous cancers
February 16, 2018 - Does Your Valentine Have a Roving Eye? Watch Out
February 16, 2018 - All Your MIPS Questions Answered — Sort Of
February 16, 2018 - Mitochondria may protect brain against Parkinson’s
February 16, 2018 - Key proteins could help in controlling the risk of osteoarthritis during aging, Study finds
February 16, 2018 - New review examines effectiveness of cupping therapy in athletes
February 16, 2018 - Resolving Interfacial Protein Dynamics by STReM
February 16, 2018 - Study provides new insights on why healthy children die from flu
February 16, 2018 - Self-sampling followed by HPV testing can benefit women at risk of cervical cancer
February 16, 2018 - Biomedical engineers grow living windpipe structures from self-assembled modules
February 16, 2018 - New device could allow people with disabilities to live more independently, enhance their quality of life
February 16, 2018 - Research identifies gene variants that play key role in how ovarian cancer patients process chemotherapy
February 16, 2018 - iMedicalApps: OB Wheels App Review
February 16, 2018 - To improve self-control, call weight loss what it is: Difficult
February 16, 2018 - Cervical tumors may be vulnerable to therapies that attack cancer’s fuel supply, study shows
February 16, 2018 - Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant – an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine
February 16, 2018 - Morning Break: Hello Not-So-Fresh; One Eye, 14 Worms; Foreign Accent Syndrome
February 16, 2018 - New medical advances marking the end of a long reign for ‘diet wizards’
FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep

FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep

image_pdfDownload PDFimage_print

FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep

Parsippany, NJ – November 29, 2017 – 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.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.

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.

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

Source: Ferring Pharmaceuticals Inc.

Posted: November 2017

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) FDA Approval History

Tagged with:

About author

Related Articles