F.D.A. Approves Powerful New Opioid Despite Warnings of Likely Abuse

NEW YORK TIMES

The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years. Although the F.D.A. advisory committee charged with evaluating the new formulation ultimately recommended in a 10-3 vote last month that the agency approve it, the panel’s chairman, Dr. Raeford Brown, wrote a letter to top F.D.A. officials afterward expressing deep concern.

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