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.

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Posted by CAROL on 11 Nov 08 10:02 PM EST

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