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News From the Food and Drug Administration
December 4, 2002

Two Drugs for Opioid Dependence

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JAMA. 2002;288(21):2678. doi:10.1001/jama.288.21.2678-JFD20012-3-1

The FDA has approved buprenorphine hydrochloride and buprenorphine hydrochloride combined with naloxone hydrochloride (Subutex and Suboxone; Reckitt Benckiser Pharmaceuticals, Slough, England) for the treatment of opioid dependence. Buprenorphine is a partial agonist at the µ-opioid receptor and an antagonist at the κ-opioid receptor. Naloxone is an antagonist at the µ-opioid receptor.

The FDA approval was based on the results of three studies involving 1219 heroin-addicted subjects: two 4-month double-blind, randomized studies of an ethanolic solution of buprenorphine (one active-controlled and one dose-controlled), and a 1-month, double-blind, randomized, placebo-controlled study of Subutex and Suboxone tablets. Based on retention in treatment and the percentage of negative urine test results for nonstudy opiates collected 3 times per week, Subutex and Suboxone at doses of approximately 12 to 16 mg/d were shown to be effective in the treatment of opiate dependence.