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Acamprosate-Campral drug gets FDA nod

Saturday, July 31, 2004

The first goverment-approved drug in a decade to treat alcoholism brings sorely needed help for the 14 million Americans battling booze says a top addiction doctor. "People with this disease don't need to suffer, and family and neighbors don't need to be silent,'' said Dr. David Gastfriend, director of addiction research at Massachusetts General Hospital.

The Food and Drug Administration approved Campral, known as acamprosate. The daily pill is believed to ease withdrawal symptoms by quieting areas in the brain that become hyperexcited after drinking alcohol is stopped. Acamprosate has been used for years in Europe but is one of only three FDA-approved drugs for alcoholism. Side effects include headache, diarrhea and nausea.

Also in the works is a new drug called Vivitrex, by Cambridge-based biotech Alkermes.

Gastfriend said final clinical trials showed Vivitrex, which would be injected monthly, reduced heavy drinking rates in men by nearly 50 percent but did not produce significant differences for women.