Sebela Pharmaceuticals has secured the US Food and Drug Administration (FDA) approval for its sodium sulphate, magnesium sulphate, and potassium chloride (SUTAB) tablets for colonoscopy preparation.
SUTAB tablet is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy, developed and planned to be marketed by Braintree Laboratories, a part of Sebela Pharmaceuticals.
Braintree offers SUPREP Bowel Prep Kit (sodium sulphate, potassium sulphate and magnesium sulphate) oral solution for colonoscopy preparation.
SUTAB is said to provide patients and physicians with an alternative to liquid-based colonoscopy preparations.
Sebela Pharmaceuticals president and CEO Alan Cooke said: “Gastroenterologists and their patients have repeatedly asked for a safe and efficacious tablet bowel prep.
“Now patients can benefit from SUTAB, thanks to Braintree’s innovative and dedicated team, who have worked tirelessly to develop this important product. SUTAB’s FDA approval underscores Braintree’s more than 35-year commitment to gastroenterology.”
The company said that colonoscopy is a common detection method for colorectal cancer, which causes cancer-related deaths and can be effectively managed through screening.
Colonoscopy is considered the gold standard of colorectal cancer screening methods, as it facilitates viewing complete colon, and help detect and remove polyps in a single procedure.
Cleaning the colon would help healthcare providers visualise the inside of a colon more clearly during a colonoscopy.
The company said that SUTAB was effective in bowel cleansing for 92% of patients and effective in cleansing all parts of the colon, including proximal colon in 92% to 95% of patients.
Also, 91% of patients in a clinical trial rated SUTAB as very easy and tolerable to consume, and 78% of the patients said they would request SUTAB again for a future colonoscopy.
University of South Alabama college of medicine gastroenterology division director Jack A Di Palma said: “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.
“And because SUTAB contains the active sulphate ingredients similar to SUPREP, gastroenterologists will already be familiar with its effects.”
Sebela is a speciality pharmaceutical company engaged in developing and commercialising gastroenterology, women’s health, and dermatology prescription products.
Braintree offers gastroenterology therapy for bowel cleansing prior to the colonoscopy and has developed various prescription bowel prep and constipation products including SUTAB, SUPREP Bowel Prep Kit, GoLYTELY and NuLYTELY.
