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FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
Date:10/12/2010

SILVER SPRING, Md., Oct. 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

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Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

"Addiction is a serious problem in this country, and can have devastating effects on individuals who are drug-dependent, and on their family members and society," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "This drug approval represents a significant advancement in addiction treatment."

The safety and efficacy of Vivitrol were studied for six months, comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. Thirty-six percent of the Vivitrol-treated patients were able to stay in treatment for the full six months without using drugs, compared with 23 percent in the placebo group.

Patients must not have any opioids in their system when they start taking Vivitrol; otherwise, they may experience withdrawal symptoms from the opioids. Also, patients may be more sensitive to opioids while taking Vivitrol at the time their next scheduled dose is due. If they miss a dose or after treatment with Vivitrol has ended, pati
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SOURCE U.S. Food and Drug Administration
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