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.
But critics say it is a mistake for the FDA to approve a new powerful opioid while the United States is experiencing an epidemic of overdoses and deaths from the drugs. Dr. Anna Lembke, chief of the Stanford University Addiction Medicine Dual Diagnosis Clinic, said that there are already enough opioids available.
“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.”
Dr. Raeford Brown chairs the advisory panel that recommended approval of the drug but was unable to attend the meeting regarding Dsuvia. He argued against the drug in a letter sent to Gottlieb in October.
“I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market,” Brown wrote.
Brown and colleagues who co-signed the letter strongly urged Gottlieb to “reject this needless and dangerous addition to the FDA-approved opioid armamentarium. It has no truly unique benefits and will only add to the worsening, not the mitigation, of the opioid epidemic in this country.”
They also noted that opioids already in use are not adequately regulated and controlled.
“Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”
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