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BMJ 2011; 342 doi: (Published 04 May 2011) Cite this as: BMJ 2011;342:d2755

FDA’s approval of depot naltrexone undermines scientific, regulatory, and ethical standards, say critics

A group of international experts has criticised the US Food and Drug Administration (FDA) for approving a depot form of naltrexone for heroin addiction after a single placebo controlled trial conducted in Russia. The new formulation worked, but a linked comment (doi:10.1016/S0140-6736(10)62056-9) charges the FDA with undermining scientific and ethical standards by accepting evidence from a placebo controlled trial that denied participants an active comparator, such as methadone maintenance. Accepted comparator treatments are available in the US (where depot naltrexone is now licensed) but not in Russia, where the new drug’s manufacturers chose to conduct their trial. “The testing of depot naltrexone in Russia is akin to finding a location with no access to antiretrovirals and then testing a new HIV drug against placebo,” they write.

Questions are already being asked about the safety of depot naltrexone as a treatment for addiction. Dozens of deaths associated with depot naltrexone for alcohol addiction were reported to the FDA between 2006 and 2010. Fatal overdose is a well documented risk associated with oral naltrexone for heroin …

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