Injectable extended-release naltrexone for opioid dependence.

摘要

Daniel Wolfe and colleagues1 suggest that the US Food and Drug Administration (FDA) "lowered its scientific, regulatory, and ethical standards" in approving a depot version of naltrexone (Vivitrol) for the prevention of relapse to opioid dependence after opioid detoxification. These standards were not compromised. Approval was based, in part, on data from a Russian clinical trial2 that used a placebo control rather than an active comparator such as methadone or buprenorphine-a study design Wolfe and colleagues criticise for denying patients standard therapy. In fact, many patients, even where methadone is available, choose not to use, or are not candidates for, methadone treatment. Vivitrol is intended for use in these patients after they are no longer physically opioid-dependent, and the trial tested (and showed) its efficacy in that setting. Since many US patients choose not to seek agonist maintenance treatment, or prefer short-term withdrawal followed by drug-free or naltrexone treatment, these data are clearly applicable to the US population. An FDA Psychopharmacologic Drugs Advisory Committee convened in September, 2010, agreed with this conclusion.