The U.S. Food and Drug Administration (FDA) has approved a new form of the synthetic opioid sufentanil for the management of acute pain in adults. The approval is based on a decision from the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which voted 10-3 recommending approval.
The approved drug is 10 times stronger than fentanyl, which has long been used for pain management, but also has been identified as a leading cause of the U.S. opioid addiction and overdose crisis. The approval of an even more powerful opioid has led to concern that without strict controls, the drug could be diverted from medical use and end up in the hands of addicts.
While AADPAC voted to approve the drug, the committee’s chairman, Raeford Brown, MD, who was not present for the vote, subsequently wrote a letter to top FDA officials expressing his objections. “[The new drug] is so potent that abusers of this intravenous formulation often die when they inject the first dose,” he wrote. “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.”
However, FDA Commissioner Scott Gottlieb, MD, defended the agency’s decision to approve the drug, emphasizing that it will be distributed only by health-care providers in single doses within hospitals and other supervised medical facilities. “As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market,” he said. “We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.”
The new form of sufentanil will likely become available in early 2019.