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Naltrexone Drug [Vivitrol] Wins Initial FDA Approval

 
Anonymous Author; News Summaries, Join Together; 2006-01-03 Posted: 2006-01-11
[Identifier=http://www.doctordeluca.com/Library/AddictionMeds/VivetrolWinsFdaApp06.htm]

 
[Source = http://www.jointogether.org/sa/news/summaries/reader/0%2C1854%2C578813%2C00.html]
 
Related Resources:

The Naltrexone Collection
 ;  Abstinence,  Harm Reduction, and the Great Debate  ; 
 
Pharmacotherapy of Substance Use Disorders Collection
 
See also:
Efficacy and Tolerability of Long-Acting Injectable Naltrexone [Vivitrex] for Alcohol Dependence - Garbut et al.; JAMA; 2005
 
Naltrexone for Patients who Wish to Moderate Their Drinking: An Annotated Guide to Clinical Research - DeLuca; 2002 /2005
 


The U.S. Food and Drug Administration has granted conditional approval to Vivitrol, a once-a-month, naltrexone-based drug intended to curb craving for alcohol, Reuters reported Dec. 29.

The injectable drug, developed by Alkermes, Inc., is expected to hit the market in 2006. The company still has to provide FDA with additional data on the drug and meet other requirements in order to get full approval for Vivitrol.

Alkermes officials said that the drug will initially be marketed to people already in treatment for alcoholism. "At launch, our focus is on those patients who are motivated to stop" drinking, said Alkermes Chief Executive Officer Richard Pops. "There (are) enough patients in that 2.3 million people to have an enormous medical impact."

Some market analysts said that annual sales of the drug could top $500 million. "We believe Vivitrex could become the gold standard for treatment of alcohol dependence, particularly for patients with compliance issues," CIBC World Market analysts recently wrote.

Pops said having a monthly form of naltrexone "removes the need for daily decision making" about alcohol use.

[END]

 

Dr. DeLuca's Addiction, Pain, and Public Health Website

Alexander DeLuca, M.D.

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Originally posted: 2006-01-11

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