Despite warnings of potential abuse, the U.S. Food and Drug Administration approved a new opioid drug last week that is 10 times stronger than fentanyl. The drug, Dsuvia, is a new formulation of sufentanil, a powerful painkiller that has been used in hospitals intravenously for decades. The new version is a tablet that is administered under the tongue with a single-use applicator.
FDA Commissioner Scott Gottlieb said in a statement announcing the approval that the drug would only be used by medical professionals.
“The medicine is restricted to use in certified medically-supervised healthcare settings‒such as hospitals, surgical centers and emergency departments‒for administration by a healthcare professional,” Gottlieb said.
Gottlieb also said that Dsuvia would be subject to strict restrictions on dispensing and use to help prevent abuse of the drug.
“It can’t be dispensed to patients for home-use and should not be used for more than 72-hours,” he said. “And it should only be administered by a healthcare provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home. 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.”
Gottlieb noted that the drug was developed in conjunction with the Department of Defense for use in situations where the use of intravenous drugs is not practical.
“This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said.
Critics Warn of Potential for Abuse
But critics