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Two Drugs for Opioid Dependence
JAMA. 2002;288:2678.
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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  -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.
The most frequent adverse events were headache (36.4% for Suboxone, 29.1% for Subutex . . . [Full Text of this Article]
Mark B. McClellan, MD, PhD
Commissioner of Food and Drugs
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
Methods of Detoxification and Their Role in Treating Patients With Opioid Dependence
O'Connor
JAMA 2005;294:961-963.
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