The U.S. Food and Drug Administration (FDA) has approved a powerful new opioid, Dsuvia, saying it would side with its advisory panel—despite some groups saying it’s bad timing to approve a new opioid amid rampant abuse and overdoses across the United States.
Reports have noted the drug is several times stronger than fentanyl, which has been blamed for a spike in opioid-related overdoses and deaths in recent years. Fentanyl is up to 100 times more potent than morphine, and many times that of heroin.
See here for a visual example of a deadly dose of heroin and that of fentanyl.
“There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis,” said
FDA Commissioner Scott Gottlieb in response to concerns that the drug would be abused. “We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia,” he said adding that a risk evaluation strategy will be applied to the drug.
He explained further that Dsuvia “is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator.” Gottlieb described Sufentanil as a more potent version of fentanyl that was approved in the United States in 1984.
Meanwhile, he added: “The medicine is restricted to use in certified medically-supervised health care settings—such as hospitals, surgical centers and emergency departments—for administration by a health care professional.”
The drug, which was approved by European Medicines Agency in July, 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,” Gottlieb said.
Dsuvia is manufactured by AcelRx Pharmaceuticals in single-dose 30-milligram tables. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 in favor of approving the drug, Fortune magazine
reported.
More than 71,500 Americans have died of drug overdoses in 2017, according to provisional
data released Aug. 15 by the Centers for Disease Control and Prevention. More than 40 percent of those deaths can be attributed to synthetic opioids such as fentanyl.
Most illegal fentanyl is manufactured in China and is brought through the U.S.-Mexico border or mailed to the United States. Notably, “Dilbert” creator Scott Adams’s stepson died of a
fentanyl overdose on Oct. 1.
Adams said he thinks the fentanyl was made in China, telling viewers that the United States is “
at war“ with Chinese drugmakers.
Dr. Raeford Brown, chair of the FDA advisory committee on analgesics and anesthetic drug products, told
ABC News that he was “very disappointed by the decision.”
“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” Brown added to ABC News. “The need to put a drug like this on the market is not demonstrated. The ability to manage that drug once it gets past the FDA is not demonstrated.”
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