FDA Approves Sublingual Opioid Despite Controversy

The FDA has approved the sublingual opioid sufentanil (Dsuvia) for the treatment of moderate-to-severe acute pain, despite controversy surrounding the drug’s release.

Because the drug is dispensed via a single-dose applicator under medical supervision, it is “ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible,” according to FDA Commissioner Scott Gottlieb, MD.

Due to the drug’s strength (sufentanil is up to 10 times stronger than fentanyl), critics have expressed concern about the potential for abuse.

“To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use. It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home,” Gottlieb wrote.  

“These measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse of Dsuvia, as well reduce the potential for diversion. Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia.”

—Michael Potts

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids [press release]. November 2, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624968.htm.