The Food and Drug Administration approved a controversial new opioid formulation this month, even as critics warned that it would likely be abused.
The drug, called Dsuvia, is a synthetic opioid that’s 10 times more powerful than fentanyl, the potent synthetic opioid implicated as a driving force in the 72,000 drug overdose deaths the United States logged in 2017.
The newly approved formulation of Dsuvia is a tablet version that goes under the tongue. Hospitals have administered it in IV and epidural forms for decades.
FDA Commissioner Dr. Scott Gottlieb said in a statement that the Dsuvia tablet’s “unique” delivery device, which is a single-dose applicator, would only be used in medical settings. He also pointed to the potential for the military to use the pain medication on the battlefield, where using an IV is impractical or impossible.
However, the chairman of the FDA advisory committee that approved the new drug has spoken out against the decision.
Dr. Raeford Brown, who could not attend the advisory meeting, wrote a letter to Gottlieb and the FDA in October, urging the agency not to approve what he called the “extremely divertible drug,” meaning it was likely to be funneled from medical centers to the street.
“I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market,” Brown wrote.
Dr. Anna Lembke, chief of the Stanford University Addiction Medicine Dual Diagnosis Clinic and author of the book Drug Dealer, MD, stressed that hospitals already have plenty of ways to administer opioids and don’t need another, particularly when weighed against the potential risks of the potent new formulation.
“There is no need for another opioid on the market, particularly one as potentially lethal as Dsuvia,” Lembke said. “In the midst of the worst opioid epidemic in U.S. history, the FDA seems to be operating in a vacuum, without regard for optics or public health.”
Four Democratic senators ― Edward Markey (D-Ma.), Richard Blumenthal (D-Ct.), Claire McCaskill (D-Mo.) and Joe Manchin (D-W.Va.) ― also opposed the drug’s approval.