In an unusual move, the chair of a Food and Drug Administration panel is defying a recommendation that his own panel made last week to endorse a powerful opioid painkiller, because he believes the drug represents a “danger” to public health. And to make sure his views are known, Dr. Raeford Brown, the panel chair, conveyed his concerns in a letter on Thursday to FDA officials.
At issue is Dsuvia, which the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee last Friday voted 10-to-3 to recommend for combating moderate-to-severe acute pain, but only for adults in medically supervised settings. The drug is a tablet version of an opioid that is marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.
Last year, the FDA refused to approve the medicine over concerns about usage directions and a need for additional safety data. The rejection came amid a growing outcry over opioids, which has made the agency cautious about issuing new approvals. But at the meeting last week, the manufacturer, AcelRx Pharmaceuticals (ACRX), persuaded the committee that its risk management strategy could work.
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