FDA Approves Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Colonoscopy Preparation that Tastes Just like a Sports activities Drink

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FDA Approves Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Colonoscopy Preparation that Tastes Just like a Sports activities Drink

BRAINTREE, Mass., June 22, 2023 /PRNewswire/ — Sebela Prescription drugs as we speak introduced that the U.S. Meals and Drug Administration (FDA) granted approval of Suflave (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral answer), for colonoscopy preparation in adults. Suflave, a low-volume, protected and efficient colonoscopy preparation – with a style just like a lemon-lime sports activities drink – was developed and can be marketed by Braintree Laboratories, a frontrunner in gastroenterology and a part of Sebela Prescription drugs.

The present lively screening charge in the USA for colorectal most cancers (CRC) is 72%, leaving 28% unscreened, which contributes to 153,000 CRC diagnoses and greater than 52,000 deaths yearly.i,ii Colonoscopy is the most typical detection technique for colorectal most cancers, a number one reason behind cancer-related deaths that may be managed extra successfully via screening and early detection.iii Profitable colonoscopy screening relies upon enough cleaning of the colon.iv Regardless of this, obtainable strategies of liquid preparation aren’t extensively accepted by sufferers as a result of giant volumes of poor-tasting options, leading to low affected person compliance and the necessity for repeat screenings.

Moreover, colonoscopy preparation merchandise and processes are generally cited as a major affected person barrier to colon most cancers screening,v reinforcing an unmet want amongst sufferers for higher bowel preparation choices. Tolerance of bowel preparation stays the most important deterrent for sufferers contemplating screening colonoscopy with 71% of sufferers saying it is the worst a part of colonoscopy and 55% indicating it was the best deterrent to a future colonoscopy.vi Prep quantity, palatability and affected person training are three key components in lowering prep hesitancy.

“Sufferers regularly wrestle with the style and quantity of conventional bowel preparations – and concern associated to the preparation also can negatively impression affected person willingness to endure follow-up colonoscopy whether it is indicated,” mentioned Douglas Ok. Rex, M.D., Distinguished Professor Emeritus at Indiana College Faculty of Medication and a full time working towards medical gastroenterologist. “I imagine the palatable lemon-lime taste of Suflave can be a welcomed possibility for sufferers – lowering preparation hesitancy and giving extra individuals the prospect to really feel snug throughout preparation and getting a profitable and efficient process.”

In a head-to-head pivotal research versus SUPREP® Bowel Prep Package, (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Answer, 94% of sufferers achieved profitable bowel cleaning with Suflave. The vast majority of sufferers reported that Suflave tastes like a sports activities drink, and 79% of sufferers discovered the style impartial to very nice in comparison with SUPREP (54%). Moreover, 87% of sufferers discovered Suflave tolerable to very straightforward to eat, and 80% of sufferers reported that they’d ask for Suflave for a subsequent colonoscopy. Charges of gastrointestinal opposed occasions with Suflave have been low (<8%).vii

“We imagine in affected person alternative and are dedicated to bettering the colon preparation course of for sufferers. We’re delighted with the FDA’s approval of Suflave – which has efficacy equal to SUPREP, however with style just like a sports activities drink,” mentioned Alan Cooke, President and CEO of Sebela Prescription drugs. “We’re pleased with the laborious work and dedication of the Braintree group and the part 3 trials investigator group who proceed to deliver new, higher decisions to individuals present process colonoscopy screening.”

Suflave is the most recent innovation in colonoscopy preparation from Braintree Laboratories. In November 2020, the FDA accepted the corporate’s pill preparation, SUTAB®, which has had a wonderful adoption report with use by over 2 million sufferers.

Suflave can be obtainable by prescription to sufferers within the U.S. in early August.

IMPORTANT SAFETY INFORMATION

Suflave(polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral answer) is an osmotic laxative indicated for cleaning of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION: A low residue breakfast could also be consumed on the day earlier than colonoscopy, adopted by clear liquids as much as 2 hours previous to colonoscopy. Administration of two doses of Suflave are required for an entire preparation for colonoscopy. Every bottle should be reconstituted with water earlier than ingestion. Every bottle and one flavor-enhancing packet are equal to at least one dose. A further 16 ounces of water should be consumed after every dose. Cease consumption of all fluids not less than 2 hours earlier than the colonoscopy.

CONTRAINDICATIONS: Use is contraindicated within the following situations: Gastrointestinal obstruction or ileus, bowel perforation, poisonous colitis or poisonous megacolon, gastric retention, hypersensitivity to any ingredient in Suflave.

WARNINGS AND PRECAUTIONS: Danger of fluid and electrolyte abnormalities: Encourage enough hydration, assess concurrent drugs and contemplate laboratory assessments previous to and after every use; Cardiac arrhythmias: Think about pre-dose and post-colonoscopy ECGs in sufferers at elevated threat; Seizures: Use warning in sufferers with a historical past of seizures and sufferers at elevated threat of seizures, together with drugs that decrease the seizure threshold; Colonic mucosal ulcerations: Think about potential for mucosal ulcerations when decoding colonoscopy findings in sufferers with identified or suspected inflammatory bowel illness; Sufferers with renal impairment or taking concomitant drugs that have an effect on renal operate: Use warning, guarantee enough hydration and contemplate laboratory testing; Suspected GI obstruction or perforation: Rule out the analysis earlier than administration; Sufferers in danger for aspiration: Observe throughout administration; Hypersensitivity reactions, together with anaphylaxis: Inform sufferers to hunt fast medical care if signs happen.

ADVERSE REACTIONS: Most typical opposed reactions (> 2%) are: nausea, stomach distension, vomiting, stomach ache, and headache.

DRUG INTERACTIONS: Medication that improve threat of fluid and electrolyte imbalance. See Full Prescribing Info and Remedy Information

About Sebela Prescription drugs

Sebela Prescription drugs is a US pharmaceutical firm with a market main place in gastroenterology and a deal with innovation in girls’s well being. Braintree, part of Sebela Prescription drugs, is the market chief in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of progressive prescription colonoscopy preparations and a number of gastroenterology merchandise. Braintree additionally has a number of gastroenterology applications in late-stage medical improvement together with Tegoprazan which is in part 3 trials for gastro-esophageal reflux illness (GERD), particularly, erosive esophagitis (EE) and non-erosive reflux illness (NERD). As well as, Sebela Ladies’s Well being has two subsequent era intra-uterine gadgets (IUDs) for contraception within the remaining levels of medical improvement. Sebela Prescription drugs has places of work/operations in Roswell, GA; Braintree, MA; and Dublin, Eire; has annual web gross sales of roughly $200 million; and has grown to over 320 workers via strategic acquisitions and natural progress.

Please go to sebelapharma.com for extra info or name 800-874-6756.

Ahead-looking Statements

This press launch and any statements made for and through any presentation or assembly comprise forward-looking statements associated to Sebela Prescription drugs beneath the protected harbor provisions of Part 21E of the Non-public Securities Litigation Reform Act of 1995 and are topic to dangers and uncertainties that might trigger precise outcomes to vary materially from these projected. These statements could also be recognized by means of forward-looking phrases resembling “anticipate,” “deliberate,” “imagine,” “forecast,” “estimated,” “anticipated,” and “intend,” amongst others. There are a selection of things that might trigger precise occasions to vary materially from these indicated by such forward-looking statements. These components embody, however aren’t restricted to, the event, launch, introduction and industrial potential of Suflave; progress and alternative, together with peak gross sales and the potential demand for Suflave, in addition to its potential impression on relevant markets; market measurement; substantial competitors; our skill to proceed as a rising concern; our want for extra financing; uncertainties of patent safety and litigation; uncertainties of presidency or third-party payer reimbursement; dependence upon third events; our monetary efficiency and outcomes, together with the danger that we’re unable to handle our working bills or money use for operations, or are unable to commercialize our merchandise, inside the guided ranges or in any other case as anticipated; and dangers associated to failure to acquire FDA clearances or approvals and noncompliance with FDA rules. As with all pharmaceutical beneath improvement, there are important dangers within the improvement, regulatory approval and commercialization of latest merchandise. There are not any ensures that future medical trials mentioned on this press launch can be accomplished or profitable or that any product will obtain regulatory approval for any indication or show to be commercially profitable. Whereas the record of things offered right here is taken into account consultant, no such record ought to be thought-about to be an entire assertion of all potential dangers and uncertainties. Unlisted components might current important extra obstacles to the conclusion of forward-looking statements. Ahead-looking statements included herein are made as of the date hereof, and Sebela Prescription drugs doesn’t undertake any obligation to replace publicly such statements to replicate subsequent occasions or circumstances besides as required by legislation.

i Facilities for Illness Management and Prevention. (2023, March 22). Colorectal (colon) most cancers statistics. Heart for Illness Management and Prevention. Retrieved June 12, 2023, from https://www.cdc.gov/most cancers/colorectal/statistics/use-screening-tests-BRFSS.htm#data-table-undefined

ii Colorectal most cancers – statistics. Most cancers.web (2023, February). Retrieved June 12, 2023, from https://www.most cancers.web/cancer-types/colorectal-cancer/statistics

iii Doubeni CA, Corley DA, Quinn VP, et al. Effectiveness of screening colonoscopy in lowering the danger of dying from proper and left colon most cancers: a big community-based research. Intestine. 2018;67(2):291-298

iv Harrison, N. M., & Hjelkrem, M. C. (2016). Bowel cleaning earlier than colonoscopy: Balancing efficacy, security, price and affected person tolerance. World journal of gastrointestinal endoscopy, 8(1), 4–12. https://doi.org/10.4253/wjge.v8.i1.4

v Romero, R. V., & Mahadeva, S. (2013). Components influencing high quality of bowel preparation for colonoscopy. World journal of gastrointestinal endoscopy, 5(2), 39–46. https://doi.org/10.4253/wjge.v5.i2.39

vi emulapalli KC, Lahr RE, Rex DK. 2021 Affected person Perceptions Relating to Colonoscopy Expertise. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689. PMID: 35324481.

vii Knowledge on File, Braintree, MA: Braintree Laboratories, Inc.

SOURCE Sebela Prescription drugs

Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) FDA Approval Historical past

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