FDA Approves Sutab Tablets for Colonoscopy Preparation

Sebela Pharmaceuticals has received FDA approval for sodium sulfate, magnesium sulfate, and potassium chloride tablets (Sutab) for colonoscopy preparation, as an alternative to liquid-based colonoscopy solutions.

Sutab is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. When taking Sutab, a low residue breakfast may be consumed, but only clear liquids can be consumed until after the colonoscopy. Twelve tablets are equivalent to 1 dose and water must be consumed with each dose.

Colonoscopies are the most common method of detecting colorectal cancer, which is a leading cause of cancer-related deaths. Screening for colorectal cancer is an essential way to screen and catch the disease earlier, improving patient prognoses. According to a press release, colonoscopies are considered the gold standard of colorectal screening methods for the ability to view the entire colon and both detect and remove polyps during the same procedure. Nineteen million colonoscopies are performed annually in the United States.

“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,” said Douglas K. Rex, MD, director of endoscopy at Indiana University Hospital, in a press release. “Tablets provide a welcome alternative for successful prep completion and visualization of the colon.”

In 2 pivotal trials, 92% of patients achieved successful bowel cleansing with Sutab and 92% to 95% of patients achieved successful cleansing in all segments of the colon, including the proximal colon. In one trial, 91% of patients rated Sutab as very easy to tolerable to consume, and 78% said they would request Sutab again for a future colonoscopy.

Finally, 52% of all Sutab and MoviPrep patients reported at least 1 selected gastrointestinal adverse reaction, and more Sutab patients reported experiencing nausea and vomiting than patients who took the comparator.

“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, past-president of the American College of Gastroenterology, in the press release. “And because Sutab contains the active sulfate ingredients similar to Suprep, gastroenterologists will already be familiar with its effects.”

REFERENCE

Sebela Pharmaceuticals Receives FDA Approval for SUTAB Tablets for Colonoscopy Preparation [news release]. PR Newswire; November 10, 2020. https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-receives-fda-approval-for-sutab-tablets-for-colonoscopy-preparation-301170374.html. Accessed November 11, 2020.