Efficacy
SUFLAVE provided equivalent cleansing to SUPREP Bowel Prep Kit: 94% vs 94%, respectively1,2
- Blinded central readers rated SUFLAVE cleansing success higher than SUPREP Bowel Prep Kit: 98% vs 94%; P=0.0232
Study Design1,2: This phase 3 trial was conducted in multiple sites. Of the 500 subjects who enrolled, 450 were evaluable for efficacy analyses. The primary endpoint was the percentage of subjects with successful cleansing, which was defined as a rating of excellent or good as assigned by the local endoscopist utilizing the US FDA Bowel Prep Scoring Scale. Independent central readers also reviewed all colonoscopy videos and provided a global cleansing grade, as well as segmental grades, on insertion and withdrawal using a 4-point scale of excellent, good, fair, and poor. The goal of the study was to establish non-inferiority of SUFLAVE to SUPREP Bowel Prep Kit, using a 10% non-inferiority margin.
*Success was defined as an overall cleansing assessment of excellent or good by the blinded endoscopist; scores were assigned following completion of the colonoscopy; P<0.001 in this non-inferiority clinical trial.
INDICATION
SUFLAVE™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing
of the colon in preparation for colonoscopy in adults.
DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are
required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor enhancing packet are equivalent to
one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy.
CONTRAINDICATIONS
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any
ingredient in SUFLAVE.
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use;
Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at
increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting
colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function:
Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.
ADVERSE REACTIONS
Most common adverse reactions (≥ 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache.
DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.
View the Full Prescribing Information and Medication Guide.
References
1. SUFLAVE [package insert]. Braintree, MA: Braintree Laboratories, Inc.
2. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894
3. Data on file. Braintree Laboratories, Inc.
4. Walker ML, Cleveland MV, Hague KM, et al. A formulation development study of BLI4900, a novel flavor enhanced bowel preparation for colonoscopy. Gastrointest Endosc. 2022;95(6 Suppl). Accessed Jan 2, 2024. https://doi.org/10.1016/j.gie.2022.04.188
5. Wiener G, Winkle P, McGowan JD, et al. A phase 2 evaluation of a new flavored PEG and sulfate solution compared to an over-the-counter laxative, PEG and sports drink bowel preparation combination. BMC Gastroenterol. 2023;23:433. doi:10.1186/s12876-023-03069-8
6. Hernández G, Gimeno-García AZ, Quintero E. Strategies to improve inadequate bowel preparation for colonoscopy. Front Med (Lausanne). 2019;6:245. doi:10.3389/fmed.2019.00245
7. D’Souza SM, Parekh PJ, Johnson DA. The dirty side of colonoscopy: predictors of poor bowel preparation and novel approaches to overcome the shortcomings. Br J Gastroenterol. 2019;1:106-115. doi:10.31488/bjg.1000103
8. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi:10.1038/ajg.2017.174
9. Corley DA, Jensen CD, Marks AR, et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014;370:1298-1306. doi:10.1056/NEJMoa1309086
10. Liem B, Gupta N. Adenoma detection rate: the perfect colonoscopy quality measure or is there more? Transl Gastroenterol Hepatol. 2018;3:19. doi:10.21037/tgh.2018.03.04
11. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. doi:10.1016/j.gie.2014.07.058
12. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
