Suflave, a Low-Volume, Colonoscopy Preparation, Gets FDA Approval

The Food and Drug Administration (FDA) has approved Suflave™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), an osmotic laxative for cleansing of the colon in preparation for colonoscopy in adults.

The approval was based on 2 randomized, single-blind, active-controlled, multicenter trials (ClinicalTrials.gov Identifier: NCT04446299 [Study 1], NCT04446312 [Study 2]) that evaluated the efficacy and safety of Suflave in adults undergoing colonoscopy for colorectal cancer screening and surveillance, or diagnostic colonoscopy. Patients were randomly assigned to receive a split-dose regimen of either Suflave or an FDA-approved comparator. 

The primary endpoint was the proportion of patients with successful bowel preparation, defined as a preparation rated as excellent or good by the blinded endoscopist on a 4-point scale.

Findings from Studies 1 and 2 showed that 93% (n=215/232) and 94% (n=212/226) of patients who received Suflave, respectively, achieved overall cleansing success compared with 89% (n=212/239) of patients who received active comparator in Study 1 (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution) and 94% (n=211/224) of patients who received active comparator in Study 2 (sodium sulfate, potassium sulfate, and magnesium sulfate oral solution).

Suflave is supplied in a carton containing 2 bottles and 2 flavor enhancing packets. Each bottle contains a white powder for reconstitution and is lemon-lime flavored. The product is expected to be available in early August.

“We believe in patient choice and are committed to improving the colon preparation process for patients.  We are delighted with the FDA’s approval of Suflave – which has efficacy equivalent to Suprep, but with taste similar to a sports drink,” said Alan Cooke, President and CEO of Sebela Pharmaceuticals. “We are proud of the hard work and dedication of the Braintree team and the phase 3 trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening.”

References

1. FDA approves Sebela Pharmaceuticals’ Suflave™ a new colonoscopy preparation that tastes similar to a sports drink. News release. Sebela Pharmaceuticals. Accessed June 23, 2023. https://www.prnewswire.com/news-releases/fda-approves-sebela-pharmaceuticals-suflave-a-new-colonoscopy-preparation-that-tastes-similar-to-a-sports-drink-301858251.html

2. Suflave. Package insert. Sebela Pharmaceuticals; 2023. Accessed June 23, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215344s000lbl.pdf

This article originally appeared on MPR