FDA APPROVES VIVITROL FOR ALCOHOL DEPENDENCE

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The FDA has approved Vivitrol, the first once-monthly injectable medication to treat alcohol dependence, reported drugmakers Alkermes and Cephalon.

Vivitrol (naltrexone for extended-release injectable suspension) is indicated for alcohol-dependent patients who are able to abstain from drinking in an outpatient setting and not actively drinking at the time treatment begins.

Alcoholism is a prevalent disease that affects nearly 10 percent of the U.S. adult population, with an estimated 100,000 Americans expected to die each year from alcohol-related disease or injury, according to the Agency for Health Care Policy and Research (AHCPR), a branch of the Agency for Healthcare Research and Quality. The annual cost to the nation has been estimated to exceed $166 billion, the agency says.

Vivitrol works by binding to opioid receptors in the brain, which preclinical data suggest leads to the blocking of neurotransmitters linked to alcohol dependence.