Sebela Pharmaceuticals receives FDA approval for colonoscopy prep tablets

FDA approved Sebela Pharmaceuticals' sulfate-based tablet for colonoscopy preparation. The sodium sulfate, magnesium sulfate, and potassium chloride drug (Sutab) was developed and will be marketed by Braintree Laboratories, a division of Sebela. The drug gives patients and physicians an alternative to liquid-based colonoscopy preparations.

FDA approved Sebela Pharmaceuticals' sulfate-based tablet for colonoscopy preparation. The sodium sulfate, magnesium sulfate, and potassium chloride drug (Sutab) was developed and will be marketed by Braintree Laboratories, a division of Sebela. The drug gives patients and physicians an alternative to liquid-based colonoscopy preparations. In two pivotal trials, 92% of patients achieved successful bowel cleansing with the new sulfate-based tablet preparation, with 92%-95% of patients achieving successful cleansing in all segments of the colon, including the proximal colon. In one of the trials, 91% of patients rated the drug as very easy-to-tolerable to consume, and 78% said they would request the drug again for a future colonoscopy. However, more patients reported experiencing nausea and vomiting with the drug than the comparator. Sebela's sulfate-based tablet will be available by prescription to patients in the United States starting on January 1, 2021.