Opioid 10 Times Stonger Than Fentanyl Approved By FDA Amid Controversy

By Keri Blakinger 11/05/18

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said one critical health expert. 

gloved hand holding pill

Amid controversy and despite warnings from some in the medical community, the Food and Drug Administration (FDA) last week green-lit a new opioid called Dsuvia, a drug estimated to be 10 times as strong as fentanyl. 

The powerful painkiller is an under-the-tongue version of sufentanil, available in a pre-filled single-dose applicator, according to the federal agency. In theory, it would be used in hospitals, surgery centers and emergency departments.

Though it wouldn’t be available for take-home prescriptions, some worry that it will be diverted and abused—to deadly effect.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Dr. Sidney Wolfe of Public Citizen’s Health Research Group said in a press release. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

FDA Commissioner Scott Gottlieb released a statement defending his agency’s decision, highlighting the drug’s potential for use in war in light of its specific packaging and formulation.

Because it is sublingual, the painkiller doesn’t necessitate venous access and doesn’t require that the patient be alert enough to swallow. That could make it incredibly useful in extreme emergency situations, such as on the battlefield—and that’s what drew the Department of Defense to take interest in the drug. 

“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 wrote.

Indeed, the Pentagon has poured millions of dollars in funding research by AcelRx, the drug company behind Dsuvia, according to the Washington Post.

Despite the assurances Gottlieb sought to offer, his agency generated controversy not just for its decision to approve the drug, but also for the way in which they did it.

The FDA advisory committee that recommended allowing the painkiller voted 10-3 in favor of the drug—even though committee chair Dr. Raeford Brown was out of town speaking at a medical conference, according to the Washington Post.

Brown condemned the decision, raising concerns about the efficacy data and the sponsor’s response to safety questions.

“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown wrote. “I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”

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Keri Blakinger is a former drug user and current reporter living in Texas. She covers breaking news for the Houston Chronicle and previously worked for the New York Daily News and the Ithaca Times. She has written about drugs and criminal justice for the Washington Post, Salon, Quartz and more. She loves dogs and is not impressed by rodeo food. Find Keri on LinkedIn and Twitter.