BRAINTREE, Mass., May 13 /PRNewswire/ -- Braintree Laboratories, Inc. today announced that the U.S. Food and Drug Administration has approved the HalfLytely(R) 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(R) enables patients to ingest half the volume of solution traditionally required with a significant reduction in bowel-prep related discomfort, according to clinical trial results. The HalfLytely(R) and Bisacodyl Tablets Bowel Prep Kit also maintains efficacy comparable to the category-leading NuLytely(R) (PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution).
"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 Jack A. DiPalma, MD, Medical Director for Braintree. "Why is that important? 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," said Dr. DiPalma, who is also vice president of the American College of Gastroenterology and Director, Division of Gastroenterology, University of South Alabama College of Medicine. "Screening rates remain far below where they would need to be to significantly reduce the number of cancer deaths."
Beyond cancer, accurate, tolerable colonoscopy is needed to diagnose Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), that affect an estimated one million Americans. Early diagnosis and treatment of these conditions may prevent a worsening of symptoms (e.g. diarrhea, abdominal pain and fever) and complications (e.g. abscesses, malnutrition, and anemia).
HalfLytely(R)'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. Subjective ratings of fullness, cramping, nausea, vomiting and overall discomfort were captured based on a five-point scale; 1 = none (no symptom), 2 = mild, 3 = bothersome, 4 = distressing and 5 = severely distressing. In the trials, 19.1 percent of patients reported overall discomfort as bothersome to severe using the HalfLytely(R) compared to 37.3 percent of patients using the full-volume solution (4 liters).
"Bothersome-to-severe" scores for specific symptoms included:
* 9.1 percent of patients using HalfLytely (R) reported cramping compared
to 17.4 percent for those ingesting the full volume.
* 17.1 percent of HalfLytely (R) patients reported nausea compared to
31.8 percent using full volume.
* 5.9 percent of HalfLytely (R) patients reported vomiting vs. 13.7
percent of full-volume patients.
* 22.3 percent of HalfLytely (R) patients reported fullness vs. 44.1
percent with full volume.
The randomized, single-blind studies of HalfLytely(R) found no statistically significant difference in the efficacy of full-volume preparation in quality of bowel cleaning (as rated by physicians performing the colonoscopies) and the HalfLytely(R). Furthermore, HalfLytely(R) was compared to NuLytely(R), the current standard of care for full-volume (4 liter) preparations and the most prescribed preparation in the category.
"The approval of HalfLytely(R) marks that latest milestone in a decade-long effort at Braintree to systematically make bowel prep easier," said Harry P. Keegan IV, Vice President and Director of Marketing and Sales for Braintree Laboratories. "With better taste, prep time reduced to just a few hours and reduced volume, we have come a long way since the 1960s when the early colonoscopy prep required that patients be admitted to the hospital for a week of discomfort."
Braintree expects HalfLytely (R) to be available to physicians, patients, and pharmacies on Sept. 1, 2004. Interested parties can sign up to receive immediate notification of HalfLytely's(R) availability, get more information on the new treatment, or obtain the prescribing information by calling 1-800-874-6756.
Braintree Laboratories is a privately held pharmaceutical company that was founded in 1982 in Braintree, Massachusetts. Braintree has three product lines in the US market and holds leadership positions in two therapeutic categories -- gastrointestinal lavages and prescription laxatives.
* Braintree Laboratories pioneered the first gastrointestinal lavage in
1984 with the introduction of GoLYTELY(R) (PEG-3350 and electrolytes
for oral solution), which was soon adopted as a standard prepping
procedure.
* NuLYTELY(R) (PEG-3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution) is a reformulation of GoLYTELY
that provides improved taste and 52 percent less sodium than major
competitors.
* In 1999, Braintree received approval for MiraLax(TM) (polyethylene
glycol 3350, NF powder for solution), which recently became the no. 1
prescription laxative on the market.
Braintree Laboratories, Inc.