FDA approves powerful new opioid amid controversy

The Food and Drug Administration on Nov. 2 approved a new form of an extremely potent opioid, Dsuvia, just weeks after the chairman of the advisory committee that reviewed it asked the FDA to reject it on grounds that it would likely be abused.

Dsuvia, which is a tablet form of sufentanil, is 10 times stronger than fentanyl. Sufentanil is a synthetic opioid that has been used intravenously and in epidurals for over 20 years.

FDA Commissioner Dr. Scott Gottlieb emphasized that Dsuvia is delivered through a “pre-filled, single-dose applicator” and will only be permitted in hospitals, surgical centers and other medically supervised settings. It is ideally suited for certain special circumstances, Gottlieb said, particularly for soldiers wounded on the battlefield.

Dr. Raeford Brown, chairman of the analgesics and anesthetic products advisory committee, wrote a letter to Commissioner Gottlieb and other top FDA officials expressing deep concern regarding Dsuvia. Dr. Brown described Dsuvia as “an extremely divertible drug” and predicted diversion, abuse and death if the drug is made available.