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

• Published in: BMC gastroenterology 2023-12, Vol.23 (1), p.433-433, Article 433
• Main Authors: Wiener, Gregory, Winkle, Peter, McGowan, John D, Cleveland, Mark vB, Di Palma, Jack A
• Format: Article
• Language: English
• Subjects: Bowel and bladder training; Bowel prepration; Cancer screening; Colon; Colon cancer; Colonoscopy; Colorectal cancer; Composition; Dosage and administration; Drug dosages; Electrolytes; FDA approval; Gastroenterology; Gastrointestinal agents; Gastrointestinal surgery; Health aspects; Hypertension; Inflammatory bowel disease; Intestine; Intubation; Ischemia; Isotonic beverages; Laxative; Laxatives; Medical screening; Patient outcomes; Patient satisfaction; Polyethylene glycol; Questionnaires; Ratings & rankings; Sodium; Sports drink; Sports drinks; Success; Surveillance; Vomiting
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-023-03069-8

Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy. This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD. Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink. The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www. gov (NCT03328507) on 01/11/2017.