BRAINTREE, MA (May 24, 2004) – Braintree Laboratories, Inc. announced that the U.S. Food & Drug Administration has approved the HalfLytely and Bisacodyl Tablets Bowel Prep Kit (peg-3350, sodium chloride, sodium bicarbonate, potassium chloride for oral solution and bisacodyl delayed release tablets) as a prescription preparation for bowel cleansing prior to colonoscopy.
HalfLytely enables patients to ingest half the volume of solution traditionally required with a significant reduction in bowel-prep related discomfort, according to Braintree.
The HalfLytely and Bisacodyl Tablets Bowel Prep Kit also maintains efficacy comparable to the category-leading NuLytely (PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution), the company said.
“The arrival of a more tolerable bowel prep is crucial because the cramping, nausea and fullness associated with traditional prep is a major reason that people avoid having a colonoscopy,” said Dr. Jack A. DiPalma, medical director for Braintree. “Almost 90 percent of nearly 60,000 colon cancer deaths in the United States this year could have been prevented if diagnosed in the early stages through colonoscopy.” DiPalma is also vice president of the American College ofGastroenterology and director, division of Gastroenterology, University of South Alabama College of Medicine.
HalfLytely’s FDA approval is based on the agency’s review of safety and efficacy data from two U.S. Phase III clinical trials in a total of 400 patients, Braintree said.
Braintree expects HalfLytely to be available to physicians, patients, and pharmacies on Sept. 1, 2004. Braintree Laboratories is a privately held pharmaceutical company.