At a time when opioid-related overdoses kill more Americans each year than gun violence or auto accidents, many are imploring the government to enact greater oversight. These cries are apparently falling on deaf ears, as the Food and Drug Administration (FDA) announced approval of a controversial new opioid that is 10 times stronger than Fentanyl, a synthetic opioid that is itself 50 to 100 times more powerful than morphine.
The new drug Dsuvia is a tablet version of the intravenous opioid sufentanil, a synthetic opioid that has been used in hospitals since the 1980s. Dsuvia is administered under the tongue using a single-dose applicator. Advocates of Dsuvia say the potency and delivery system make the drug well-suited for military use, a point FDA Commissioner Scott Gottlieb specifically mentions in his public statement announcing the drug’s approval.
But while the FDA is adamant that the drug is only intended for use within healthcare facilities and possibly the battlefield, serious concerns that Dsuvia will be illicitly abused has been raised by several senators, advocacy groups, and the chair of the FDA’s own advisory committee.
In a public statement, the advocacy group Public Citizen criticized the approval of Dsuvia and alleged that the FDA “rigged the committee vote” to ensure the drug received a positive recommendation.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, founder and senior adviser 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. It is likely, if not certain, that that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms.”
In mid-October, the FDA advisory panel chair Dr. Raeford Brown took the rare step of publicly condemning the approval of Dsuvia, and urged the FDA to reject the drug. Dr. Brown expressed concern for not only the potency of Dsuvia, but the lack of safeguards in place to protect public health; stating:
“The agency feels that there is a capability, so far not demonstrated, to regulate this drug so that it is used only in closely controlled settings. In order to have this happen, the education of all prescribers would need to be guaranteed. This has not been demonstrated with any other opioid and, given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label.”
He further commented: “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. Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”
Dr. Brown also described his experience attempting to resuscitate medical students, physicians, and other health care providers who had overdosed on the IV version of sufentanil.
“It is so potent that abusers of this intravenous formulation often die when they inject the first dose.”
Despite these concerns, the FDA advisory committee recommended Dsuvia in a 10-3 vote. Dr. Brown says he was left out of the advisory process for Dsuvia, and was not present when his committee voted to recommend approval.
Dsuvia is expected to hit the market early next year. Gottlieb insists that the drug will not be dispensed to patients for home use or available at retail pharmacies, measures he is confident will prevent misuse and abuse. But considering the massive black market sales of opioids that dozens of doctors and healthcare providers have been caught up in, it would be naïve to pretend there isn’t a market eager to get their hands on this shiny new drug.
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