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Alcoholism Drug Vivitrol Approved By FDA

The federal agency announced through its web site, on 14th April, that the US Food and Drug Administration has approved the drug Vivitrol (TM), for the treatment of alcoholism. //

According to foodconsumer.org, Vivitrol was developed by Alkermes, Inc., which will be responsible for the manufacturing of the drug while Cephalon will take on the marketing and sales for the drug under an agreement signed June 2005 between the two companies.

The companies in a news release said the drug would be made available at a dose of 380 mg per intramuscular injection in the United States by the end of June 2006. Analysts estimate the sales for Vivitrol will fall between $300 to 500 million a year.

Vivitrol, the once-a-month injectable medication, is intended for outpatients for treatment of alcoholism. The patients should be able to abstain from drinking in an outpatient setting when initiating the treatment. Also, the drug should be used in coordination with psychosocial support such as counseling or group therapy, according to the companies.

"Vivitrol is the first once-a-month medication for alcohol dependence that ensures patients get the benefit of medication over the entire month," stated Richard Rosenthal, M.D., from St. Luke's-Roosevelt Hospital Center, New York, and Columbia University College of Physicians and Surgeons. "With Vivitrol, physicians have a new option to help treat patients with alcohol dependence, and patients have new hope to help them in their battle with this devastating disease," he added.

Alcohol dependence or alcoholism is a chronic disease that comes with common symptoms including cravings for alcohol, loss of control over alcohol drinking, withdrawal symptoms and an increased tolerance for alcohol. Alcohol dependence results in an economic burden to society that costs approximately $185 billion annually in the U.S.

Vivitrol suppresses alcohol dependence by binding to opioid re
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