Dsuvia: The Opioid 10 Times Stronger Than Fentanyl the FDA Just Approved

Dsuvia: The Opioid 10 Times Stronger Than Fentanyl the FDA Just Approved

Despite warnings of possible abuse, the U.S. Food and Drug Administration approved a new opioid medication last week that’s 10 times stronger than fentanyl. The medication, 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 using a single-use applicator.

FDA Commissioner Scott Gottlieb said in a statement announcing the approval that the medication could only be used by medical specialists.

“The medicine is restricted to use in certified medically-supervised healthcare settings‒such as hospitals, surgical centers and emergency departments‒for administration with a healthcare practitioner,” Gottlieb said.

Gottlieb also said that Dsuvia would be subject to strict limitations on dispensing and use to help prevent misuse of the medication.

“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 steps to restrict the use of the product only within a supervised healthcare setting, and not for home use, are important actions to help prevent misuse and abuse of Dsuvia, also reduce the potential for diversion. ”

Gottlieb noted that the medication was developed in conjunction with the Department of Defense to be used in situations where the use of intravenous drugs is not practical.

“This opioid formulation, along with Dsuvia’s unique delivery apparatus, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our state ’s soldiers on the battlefield,” Gottlieb said.

But critics say it’s a mistake for the FDA to approve a new powerful opioid while the United States is experiencing an outbreak 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 available on the current market, especially one as potentially lethal as Dsuvia,” Lembke said. “In the middle of the worst opioid epidemic in U.S. history, the FDA seems to be operating in a vacuum, without regard for optics or general health. ”

Dr. Raeford Brown chairs the advisory panel that recommended approval of this drug but was unable to attend the meeting regarding Dsuvia. He argued against the medication in a letter delivered to Gottlieb in October.

“I predict that we will encounter diversion, abuse, and death within the early months of its availability on the current market,” Brown wrote.

Brown and colleagues who co-signed the letter strongly urged Gottlieb to “reject this needless and dangerous accession 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 outbreak in this country. ”

They noted that opioids controlled and already in use are not adequately regulated.

“Briefly stated, for all of the opioids that have been marketed in the last ten years, there hasn’t been sufficient demonstration of security, nor has there been post-marketing assessment of who is taking the medication, how frequently prescribing is improper, and whether there was ever a reason to risk the health of the overall population by having yet another opioid available on the market. ”

Released at Fri, 09 Nov 2018 22:06:04 +0000

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