The drug was recently approved by the FDA advisory committee, but has remained controversial. (Photo: Shutterstock)
An opioid painkiller that is ten times more powerful than a drug linked to an epidemic of overdose deaths has been approved by the Food and Drug Administration (FDA)—despite the recommendation of an advisory committee's chairman to reject the drug.
The new drug, Dsuvia, is based on a synthetic opioid that has been in use since the 1980s. The new formulation is ten times stronger than fentanyl—a common opioid linked to overdose deaths.
The drug was recently approved by the FDA advisory committee, but has remained controversial. In October, Dr. Raeford Brown, chair of the committee that reviewed the drug, joined the group Public Citizen in criticizing the FDA for approving Dsuvia, also known as sublingual sufentanil. In a letter, Brown said that the drug would be easily divertible and the likelihood of abuse and overdose deaths from the drug is high.
“Lack of historical ability of the FDA to enforce controls, the pharmacologic potency of the drug, and the ease with which this drug will be diverted are some of the reasons that I would never consider this product for marketing in the U.S.,” Brown said “Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”
Scott Gottlieb, head of the FDA, defended the approval of the drug in a statement released at the same time the approval was announced. Gottlieb noted that the drug would only be used in controlled circumstances, and that it is aimed in part at helping care for soldiers wounded on the battlefield.
“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, Gottlieb said. “Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it 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. This includes potential uses on the battlefield. For this reason, the Department of Defense worked closely with the sponsor on the development of this new medicine.”
At a time when 115 Americans are dying every day from opioid overdoses, the issue has drawn the attention of lawmakers. Four Democratic Senators also weighed in on the decision to approve Dsuvia. In a letter signed by Sens. Edward Markey (Mass.), Claire McCaskill (Mo.), Richard Blumenthal (Conn.), and Joe Manchin (W. Va.), the lawmakers called for better vetting of such drugs.
“The historical ineffectiveness of opioid risk evaluation and mitigation strategies and the lack of uniform opioid prescriber education—two important issues some of us have previously raised with you and your agency—causes concern,” they wrote. “If the FDA approves Dsuvia and it is successfully diverted, unintended users will face grave risks, and it will be extremely challenging to protect them.”
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