The Food and Drug Administration (FDA) has approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride; Sebela), an osmotic laxative for cleansing of the colon in preparation for colonoscopy in adults.
Available as a sulfate-based tablet, Sutab provides an alternative to liquid-based colonoscopy preparations. The approval of Sutab was based on 2 active-controlled trials that included adults undergoing colonoscopy for colorectal cancer screening and surveillance or diagnostic colonoscopy. Both Sutab and the active comparators were administered according to a split-dose regimen.
The primary end point of both trials was the proportion of patients with successful colon cleansing, as assessed by the blinded colonoscopist utilizing a 4-point scale. Success was defined as an overall cleansing assessment of “good” (feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa) or “excellent” (no more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa).
Results showed that in both studies, 92% of patients (Study 1: 257/270; Study 2: 175/190) achieved overall cleansing success compared with 89% of patients (241/270) who received polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution (active comparator in Study 1) and 88% of patients (174/198) of patients who received sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution (active comparator in Study 2).
“The approval of Sutab provides a welcome relief for patients who struggle with the unpleasant taste issues commonly associated with other products for colonoscopy preparation,” said Jack A. Di Palma, MD, Professor of Medicine and Fellowship Program Director of the Division of Gastroenterology at the University of South Alabama College of Medicine and Past-President of the American College of Gastroenterology. “And because Sutab contains the active sulfate ingredients similar to Suprep, gastroenterologists will already be familiar with its effects.”
Sutab is supplied in cartons containing 2 bottles, each with 12 tablets, as well as a container with a 16-ounce fill line. The product is expected to be available January 1, 2021.
For more information visit sebelapharma.com.
Sebela Pharmaceuticals receives FDA approval for SUTAB® Tablets for colonoscopy preparation. [press release]. November 10, 2020.