FDA Approves Once-A-Month Injectable Drug to Fight Opiate Addiction

by Phillip Smith,

DRUG WAR CHRONICLE: The US Food and Drug Administration (FDA) announced Tuesday that it had approved a once-a-month injectable drug for use in treating opiate addiction. The drug, marketed as Vivitrol, is a form of naloxone, an opioid atagonist that blocks the action of opioids on brain cells and is currently used in responding to overdoses.

In approving Vivitrol, the FDA cited a Russian study with 250 heroin addicts that found it reduces relapse rates and blocks cravings for narcotics. In that study, after six months, 86% of subjects taking Vivitrol had stayed off opiates and were functioning in work or school, compared to only 57% who were given a placebo.

Unlike methadone and buprenorphine, which are commonly used in opiate substitution treatments, Vivitrol is not addictive and does not maintain opiate dependency. Additionally, unlike those two substitutes, Vivitrol does not need to be taken daily, but is instead administered monthly via intramuscular injection.

The approval of Vivitrol for opiate addiction is “an important turning point in our approach to treatment,” said Dr. Nora Volkow, head of the National Institute on Drug Abuse, in a statement greeting the FDA announcement.

Nearly 810,000 Americans are addicted to heroin, with more than twice that number using prescription opioids, such as Oxycontin and Vicodin, for non-prescription purposes, Volkow noted.

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1 Comment

  1. It was approved initially to treat alcohol dependence. It has not really caught on in this setting in part due to the cost $ 900 per injection month and less than impressive results.

    I think it may be more effective for opiate dependence but may have the disadvantage of some dysphoria due to the fact that it blocks to endorphins (endogenous opiods produced by the brain).

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