Naltrexone in addicted business executives and physicians

Abstract

Naltrexone, an orally administered, synthetic, long-acting narcotic antagonist, is being reviewed by the Food and Drug Administration (FDA). Specifically, the FDA is reviewing the preclinical (toxicology, reproduction and teratology, and carcinogenicity studies) and clinical (Phase I, Phase II, and Phase III) data to determine if the drug is safe and effective. When the New Drug Application (NDA) is approved, naltrexone will be available as an unscheduled prescription medication, useful as an adjunct in the maintenance of an opioid dependence-free state in former narcotic abusers. FDA approval of naltrexone for marketing will conclude more than three and a half decades of research on narcotic antagonists by the National Institute on Drug Abuse (NIDA) and its predecessors.