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Sublocade: Why a placebo arm?
Author(s) -
Knopf Alison
Publication year - 2019
Publication title -
alcoholism and drug abuse weekly
Language(s) - English
Resource type - Journals
eISSN - 1556-7591
pISSN - 1042-1394
DOI - 10.1002/adaw.32287
Subject(s) - buprenorphine , placebo , medicine , food and drug administration , fentanyl , opioid , opioid use disorder , clinical trial , anesthesia , psychiatry , alternative medicine , medical emergency , receptor , pathology
In a time when people are dying from illicit fentanyl overdoses, why would a trial for a new medication to treat opioid use disorder — a formulation of buprenorphine, already proven to be safe and effective in oral form — include a placebo arm? This was the question asked by many when the results of Indivior's trial for Sublocade, a buprenorphine injection that lasts a month, were published last month in The Lancet (see ADAW , Feb. 25). The trial results were what led to Sublocade's approval by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW , Dec. 11, 2017).