A novel prescription colonoscopy prep kit that includes nutritionally balanced bars and flavored beverages containing PEG 3350 resulted in successful colon cleansing and patient satisfaction in a phase 2 trial, according to a press release.
The randomized, colonoscopist-blinded trial ended after 65 patients completed their colonoscopy, and more than 90% of those who consumed the novel ColonaryConcepts bowel prep regimen 24 hours before colonoscopy had ‘excellent’ or ‘good’ endoscopic visibility. Patients also reported high satisfaction, and no serious adverse events occurred.
Corey A. Siegel
The manufacturer intends to publish and present trial results later this year and next year, and will meet with the FDA in August to prepare for phase 3 trials. It will also seek FDA approval under the statutory 505(b)(2) NDA regulatory pathway, according to the press release.
“We are very pleased with the results of this study, which provide strong clinical evidence supporting our approach and negate the long-held belief that fasting and the ingestion of high volumes of fluids are required for proper colonoscopy preparation,” Corey A. Siegel, MD, MS, co-founder of ColonaryConcepts, co-inventor of the investigational colon prep kit, director of the Inflammatory Bowel Disease Center at the Dartmouth-Hitchcock Medical Center, and associate professor of medicine at The Geisel School of Medicine at Dartmouth, said in the press release. “The results from this study — more than 90% of patients using the lead formulation had ‘excellent’ or ‘good’ rated colonoscopies — clearly encourage us to expand our investigations to a phase 3 clinical trial, which we plan to initiate in Q4 2016.”
“Patients participating in this clinical study reported high satisfaction,” Joshua Korzenik, MD, ColonaryConcepts co-founder, co-inventor of the investigational prep kit, faculty member at Harvard Medical School and the Director of Brigham and Women’s Hospital Crohn’s and Colitis Center, said in the press release. “That’s good news because we are determined to help make it easier for all patients to undergo regular colorectal screening — still recognized as the best way to catch this cancer at an early stage.”
Disclosures: Korzenik and Siegel are co-founders of ColonaryConcepts.