FDA approves sulfate-based tablet preparation for colonoscopy
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Sebela Pharmaceuticals received FDA approval for its sulfate-based tablet preparation for colonoscopy.
According a press release, the sodium sulfate, magnesium sulfate and potassium chloride tablet – known as SUTAB – will be marketed by Braintree Laboratories.
“Gastroenterologists and their patients have repeatedly asked for a safe and efficacious tablet bowel prep.” Alan Cooke, president and CEO of Sebela Pharmaceuticals, said in the release. “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.”
Ninety-two percent of patients achieved successful bowel cleaning with SUTAB in two trials; 91% of patients said SUTAB was very tolerable to consume in one trial. Further, 78% of patients said they would request it again for any future colonoscopies.
“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,” 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, said in the release. “And because SUTAB contains the active sulfate ingredients similar to SUPREP, gastroenterologists will already be familiar with its effects.”
According to the release, SUTAB will be available in the United States by prescription to patients by Jan. 1, 2021.
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