Efficacy

93%

of patients achieved successful bowel cleansing in a phase 2 clinical trial of SUFLAVE vs PEG-SD^5*

SUFLAVE provided higher efficacy rates compared with PEG-SD: 93% vs 84%, respectively^5†

Blinded central readers rated SUFLAVE efficacy higher than PEG-SD; P<0.05⁵:

—Central reader 1: 97% vs 74%

—Central reader 2: 97% vs 68%

98% vs 74% of SUFLAVE vs PEG-SD patients reported a better overall preparation experience (ratings of excellent to good)

Study Design^3,5: This multicenter, non-randomized, unblinded, phase 2 trial assessed 60 subjects. Since performing endoscopists were unblinded, blinded central reading was also performed using colonoscopy videos. Subjects assigned to PEG-SD received two 5-mg OTC bisacodyl laxative tablets, two 32-ounce bottles of lemon-lime–flavored sports drink (Gatorade^®), and two 119-g bottles of polyethylene glycol 3350 (PEG 3350). The primary endpoint was the percentage of subjects with successful cleansing, which was based on the US FDA Bowel Prep Scoring Scale. The goal of the study was to evaluate SUFLAVE vs PEG-SD.

*Success was defined as an overall cleansing assessment of excellent or good by the blinded endoscopist; scores were assigned following completion of the colonoscopy.

^†Numerical differences based on local endoscopists’ ratings. Statistical comparisons were not performed due to unblinded endoscopists.

SD=sports drink.

Gatorade is a registered trademark of Stokely-Van Camp, Inc.

Next: Phase 3

IMPORTANT SAFETY INFORMATION

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