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Vivitrol, a new drug that’s been highly lauded in the field of alcohol abuse prevention, is about to enter the United States drug market. With release scheduled for sometime in June 2006, Vivitrol (formerly known as Vivitrex) is “is an extended-release injectable suspension designed for monthly use and is indicated for patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when initiating treatment.”|
The makers of Vivitrol, Alkermes and Cephalon, have indicated that the drug, which has been quite successful in clinical trials, be used in conjunction with some other form of therapy, such as counseling.
The results of the final study of the drug, published in the May 3 edition of the Journal of the American Medical Association, showed the following:
• In the placebo group, the median number of heavy drinking days was reduced from 19 days per month in the month prior to the study (baseline) to six days per month over the six-months of placebo treatment.
• The Vivitrex treatment group showed a 48% further reduction in heavy drinking over the placebo group. Over the six-month treatment period, the median number of heavy drinking days was reduced from 19 days at baseline to three days per month in the Vivitex group compare to six days per month in the placebo group.
The Vivitrex Phase III trial involved 624 patients and was conducted at 24 locations throughout the United States. As suggested, use of the drug was combined with psychological therapy.
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