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Slow-Release Alcoholism Drug Expected Next Year
September 6, 2005

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Research Summary

Vivitrex, a naltrexone-based once-monthly injectable drug designed to reduce heavy drinking, could hit the market sometime next year, the Boston Globe reported Sept. 4.

Drug-maker Alkermes of Cambridge, Mass., is currently awaiting Food and Drug Administration approval of Vivitrex, expected on Sept. 30. If the agency gives the go-ahead, Alkermes could start selling the drug in early 2006, reaping as much as $300 million in annual sales.

For the drug to reach that kind of success, however, will require a strong education campaign targeting both alcoholics and doctors, experts say. "If you look at primary-care physicians, they're probably not even aware there are medications out there to treat alcoholism, to be honest," said Dr. Raye Litten of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

"I want to make sure that doctors all think of alcoholism as a chronic medical condition," said Alkermes marketing director Mona Haynes. Company CEO Richard Pops says that Vivitrex could do for addiction what Prozac did for mental-health treatment. "We're entering a period of time that when people look back on it 20 years from now, that was the time that medicalization of alcoholism began," he said.

Experts say that such a transformation will require a revolution in the addiction-treatment community. "The alcohol treatment system in the U.S. was designed in the 1970s, when all you had was group counseling and Alcoholics Anonymous," said Dr. Mark Willenbring, director of treatment research at NIAAA. ''So the system wasn't built up in a way that medications are part of the picture."

Dr. David Gastfriend, Alkermes' director of medical affairs, sees a pent-up demand for a drug like Vivitrex. "[Doctors] have been hearing [alcoholism] is a brain disease; this is the decade of the brain, so what are they supposed to do, talk more about that?" he said.

Vivitrex is a slow-release version of naltrexone, which blocks the pleasurable reactions to alcohol use.

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