FDA Approves Alternative to Traditional Colonoscopy Preparation
Sutab tablets provide an alternative to traditional liquid bowel preparation, which is hard to complete for some patients.
The FDA has approved sodium sulfate, magnesium sulfate, and potassium chloride tablets (Sutab; Sebela Pharmaceuticals) for colonoscopy preparation.
A colonoscopy is the most common method of colorectal cancer detection. Prior to a colonoscopy, patients need to complete a liquid bowel preparation.
The tablets offer patients an alternative, especially for those who have trouble completing the liquid bowel preparation. Colorectal cancer is one of the leading causes of cancer-related deaths, and screening is crucial for effective management. Every year, 19 million colonoscopies are performed in the United States.
The approval was based on 2 trials in which 92% of patients achieved successful bowel cleansing by using the tablet. Cleansing in all segments of the colon, including the proximal colon, was achieved in 92% to 95% of patients.
In one of the trials, the tablets were deemed easy and tolerable to consume in 91% of participants. A significant majority of participants, 78%, said they would use the tablets again for a future colonoscopy.
“Successful bowel prep is critical for gastroenterologists to clearly see any polyps or abnormalities, yet the immense volume of liquid prep solutions can prevent patients from adequately completing their regimens. Tablets provide a welcome alternative for successful prep completion and visualization of the colon,” said Douglas K. Rex, MD, director of Endoscopy at Indiana University Hospital and Professor, Department of Medicine, Division of Gastroenterology and Hepatology, University of Indiana School of Medicine, in a press release.
Compared with the competitor, more patients taking the tablets reported nausea and vomiting, according to the press release. More than half of patients, 52%, reported at least 1 selected gastrointestinal adverse reaction.
REFERENCE
Sebela Pharmaceuticals Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation [News Release] November 10, 2020; Braintree, MA. Accessed November 11, 2020.
