P3003 - A Phase 2 Evaluation of a New Flavored PEG and Sulfate Solution

Peter Winkle, MD, FACG¹, Gregory J. Wiener, MD, FACG², John D. McGowan, MPH³, Jack A. Di Palma, MD^4
1Cenexel, Anaheim, CA; ²GW Research, Inc., Chula Vista, CA; ³Braintree Laboratories, Inc., Braintree, MA; ⁴University of South Alabama, Mobile, AL

Introduction: This study describes a Phase 2 evaluation of a novel flavored PEG and sulfate solution (FPSS, also known as BLI4900) developed as a preparation for colonoscopy. FPSS was formulated to provide effective and safe cleansing but optimized for electrolyte balance and taste. FPSS features a sports drink-like taste similar to an unapproved OTC PEG and sports-drink combination (PEG-SD).

Methods: This multi-center, non-randomized study evaluated sequential cohorts of developmental formulations of FPSS in colonoscopy patients. FPSS and a PEG-SD control were given in split-dose (PM/AM) regimens starting the day before colonoscopy. Each FPSS dose consisted of 1 L of prep solution with 16 oz of additional water. PEG-SD was given to 19 patients (mean age 49) as 2 doses of PEG3350 (119 g) mixed with 32 oz of sports drink. The first PEG-SD dose was preceded by 10mg of bisacodyl at 3:00PM. 40 adults (mean age 58) were enrolled and prepped with the to-be-marketed FPSS formulation.

Since the performing endoscopists were unblinded, blinded central reading was also performed using video recordings. Cleansing was rated with an FDA-accepted 4-point global scale (Excellent, Good, Fair, Poor), with Good or Excellent considered a Success. Colon segments were also graded on withdrawal. Lab testing and adverse events (AEs) were collected for safety. Patient prep experience was assessed via questionnaire.

Results: A high rate of cleansing success was seen with FPSS, with 93% of preps rated as successful by performing endoscopists. Segmental success was also high (> 95%), including the right colon. PEG-SD had an overall success rate of 84%, with 89% success in the distal and transverse colon but only 69% success in the right colon. Blinded central reviewers evaluated both preps and rated the cleansing success of FPSS significantly higher than PEG-SD (Rater 1: FPSS = 97%, PEG-SD = 74%; Rater 2: FPSS = 97%, PEG-SD = 68%).

FPSS resulted in low rates of expected bowel prep symptoms. Patient acceptance scores (Table 1) were high, with 97% of FPSS patients rating their experience excellent or good versus 73.7% for PEG-SD (p< 0.05). 68% of patients agreed that FPSS tasted like a sports drink.

Discussion: This Phase 2 study confirms that FPSS is an effective prep for colonoscopy with low rates of expected AEs. It appears to provide better cleansing than PEG-SD, without the need for a stimulant laxative, while also reaching the high level of patient acceptance of PEG-SD.


Disclosures:


Peter Winkle, MD, FACG¹, Gregory J. Wiener, MD, FACG², John D. McGowan, MPH³, Jack A. Di Palma, MD⁴. P3003 - A Phase 2 Evaluation of a New Flavored PEG and Sulfate Solution, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.