BRAINTREE, Mass., Oct. 6 /PRNewswire/ -- Braintree Laboratories, Inc. today announced that 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) is available nationwide as a prescription preparation for bowel cleansing prior to colonoscopy. Available as of September 15th, 2004, and approved by the U.S. Food and Drug Administration on May 13, 2004, HalfLytely(R) enables patients to ingest half the volume of solution traditionally required, significantly reducing 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).
"We are excited to make HalfLytely available to physicians looking to make colonoscopy easier for their patients, and hope that a more tolerable bowel prep will equal more procedures to catch colon cancer before it starts," said Harry P. Keegan IV, Vice President and Director of Marketing and Sales for Braintree Laboratories. "HalfLytely marks a decade-long effort at Braintree to make the colonoscopy procedure easier. With better taste, reduced prep time and reduced volume, HalfLytely is a major advancement since the week- long, hospital-based procedures of the 1960s."
Beyond cancer, an accurate, tolerable colonoscopy is needed to diagnose Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), affecting 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 is available via prescription, at a Wholesale Acquisition Cost (WAC) of $39.00, through all major wholesale outlets (including, AmerisourceBergen, Cardinal Health and McKesson Corporation), as well as all major retail pharmacy chains (including Albertsons, CVS, Walgreen's, RiteAid, and Eckerd). Interested parties receive get more information on the new treatment, or obtain the prescribing information by calling 1-800-874-6756.
Clinical Trial Results
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 cramping, nausea and fullness associated with traditional prep is a major reason that people avoid having a colonoscopy, and 90 percent of nearly 60,000 annual colon cancer deaths in the United States could be prevented if diagnosed early through such screening examinations," said Jack A. DiPalma, MD, Medical Director for Braintree. "Making colonoscopy prep more comfortable is a significant step toward higher screening rates, and HalfLytely is part of the solution," said Dr. DiPalma, who is also vice president of the American College of Gastroenterology.
About Braintree Laboratories
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.