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halflytely
Generic Name: peg-3350, sodium chloride, sodium bicarbonate, potassium chloridefor oral solution and bisacodyl delayed release tablets
Date of Approval: May 10, 2004
Company: Braintree Laboratories, Inc.
Treatment for: Colonoscopy Preparation
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The U.S halflytely. Food and Drug Administration has approved the HalfLytely and BisacodylTablets Bowel Prep Kit as a prescription preparation for bowel cleansing priorto colonoscopy.
HalfLytely enables patients to ingest half the volume of solution traditionallyrequired with a significant reduction in bowel-prep related discomfort, accordingto clinical trial results halflytely. The HalfLytely and Bisacodyl Tablets Bowel Prep Kitalso maintains efficacy comparable to the category-leading NuLytely (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 thatpeople avoid having a colonoscopy," said Jack A halflytely. DiPalma, MD, Medical Directorfor Braintree halflytely. "Why is that important? Almost 90 percent of nearly 60,000colon cancer deaths in the United States this year could have been preventedif diagnosed in the early stages through colonoscopy," said Dr halflytely. DiPalma,who is also vice president of the American College of Gastroenterology and Director,Division of Gastroenterology, University of South Alabama College of Medicine halflytely. "Screening rates remain far below where they would need to be to significantlyreduce the number of cancer deaths."

Beyond cancer, accurate, tolerable colonoscopy is needed to diagnose Crohn'sdisease and ulcerative colitis, collectively known as inflammatory bowel disease(IBD), that affect an estimated one million Americans halflytely. Early diagnosis and treatmentof these conditions may prevent a worsening of symptoms (e.g halflytely. diarrhea, abdominalpain and fever) and complications (e.g halflytely. abscesses, malnutrition, and anemia).

HalfLytely's FDA approval is based on the agency's review of safety and efficacydata from two U.S halflytely. Phase III clinical trials in a total of 400 patients halflytely. Subjectiveratings of fullness, cramping, nausea, vomiting and overall discomfort werecaptured based on a five-point scale; 1 = none (no symptom), 2 = mild, 3 = bothersome,4 = distressing and 5 = severely distressing halflytely. In the trials, 19.1 percent ofpatients reported overall discomfort as bothersome to severe using the HalfLytelycompared 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 reported cramping compared to 17.4percent for those ingesting the full volume.
- 17.1 percent of HalfLytely patients reported nausea compared to 31.8 percentusing full volume.
- 5.9 percent of HalfLytely patients reported vomiting vs halflytely. 13.7 percent of full-volumepatients.
- 22.3 percent of HalfLytely patients reported fullness vs halflytely. 44.1 percent withfull volume.

The randomized, single-blind studies of HalfLytely found no statistically significantdifference in the efficacy of full-volume preparation in quality of bowel cleaning(as rated by physicians performing the colonoscopies) and the HalfLytely halflytely. Furthermore,HalfLytely was compared to NuLytely, the current standard of care for full-volume(4 liter) preparations and the most prescribed preparation in the category.


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