FDA approval of opioid dependence treatment comes under fire
LEADING Australian addiction medicine specialist Dr Alex Wodak has accused the US Food and Drug Administration (FDA) of lowering scientific standards to approve a treatment for opioid dependence.
In an editorial in The Lancet, Dr Wodak joins four other specialists in condemning a trial, and subsequent FDA approval, of an injectable extended-release naltrexone.
The drug, XR-NTX, was found in a randomised, placebo-controlled trial of 250 patients to be more successful than placebo in helping patients achieve abstinence following detoxification (90% vs 35%).
The trial was conducted in Russia, which