FDA approves powerful new opioid in controversial move
The Food and Drug Administration (FDA) on Friday approved a powerful new opioid drug despite concerns from advocates that it could be abused.
The drug, called Dsuvia, is 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, according to Public Citizen, an advocacy group that objected to the approval.
FDA Commissioner Scott Gottlieb acknowledged the concerns, but said that access to the drug would be strictly controlled and noted that it could be beneficial to the military.
“It fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said, noting that the drug is administered under the tongue, making it more suitable to battlefield situations where people cannot easily inject a drug.
Gottlieb said the drug would only be authorized to be administered by a health-care professional, and would not be available at pharmacies for people to take home.
“To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use,” he said.
Still, critics warned of abuse.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, founder of Public Citizen’s Health Research Group. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”