Publication date: Jan 07, 2020
In November 2018, the Food and Drug Administration approved America’s newest opioid, a formulation of sufentanil called Dsuvia.
Fueled by a combination of fentanyl panic and alarmed headlines, Dsuvia got a fair amount of negative attention in the weeks before and after its FDA approval.
Dsuvia is the first graduate of a new collaboration between the DoD and the FDA, formally announced the same day Dsuvia was approved.
None of this actually violates any FDA rules, but with respect to the DoD collaboration there appears to be one problem: Dsuvia is not a life-saving drug.
Over a period of several months, both the FDA and the DoD were either unwilling or unable to articulate to me how an opioid made it onto a list supposedly reserved for life-saving medical products, when acute pain is not a life-threatening condition.
The DoD offered conflicting or off-topic answers or else punted to the FDA, which separately declined repeated requests for comment on how the terms of the collaboration applied to Dsuvia.
A DoD representative variously emailed me that the Department had told the FDA the opioid was a priority item under the new collaboration, and that, -After checking, there was no formal request from DoD for expedited FDA action under that statute, but DoD strongly supports the FDA approval of Sufentinel [sic]. “
In the last decade, the FDA has deposited more than a dozen new opioid formulations on the shores of commercial use without much notice, but Dsuvia was not one of them.
Two weeks before the drug’s approval deadline, Dr. Raeford Brown, then-chair of the FDA advisory committee that evaluates analgesics, wrote a statement urging the FDA to reject it, arguing that IV sufentanil was -so potent that abusers of this intravenous formulation often die when they inject the first dose” and that abuse of Dsuvia would likely begin -within the early months of its availability on the market. “
Two weeks after the drug’s approval, Brown co-wrote an op-ed in the Washington Post saying that the FDA had made a grave mistake, that Dsuvia had -limited efficacy and no unique benefits,” and implying that it would have a similar-but-worse impact on the overdose crisis as fentanyl.
The op-ed also stated that all but three members of the FDA’s drug safety advisory committee had been disinvited from the hearing ahead of Dsuvia’s approval.
FDA spokesperson Deborah Kotz told me certain members were absent due to scheduling conflicts; Dr. Pamela Palmer, co-founder and Chief Medical Officer of the company behind Dsuvia, AcelRx Pharmaceuticals, said they hadn’t been invited in the first place; Brown maintained they were disinvited.
The drug’s official FDA indication is -for use in adults in a certified medically supervised setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. “
Because that ER study was open-label-meaning that, unlike with more rigorous studies, there was no placebo group-a 2017 FDA clinical review found it insufficient to support Dsuvia’s efficacy, and it was removed from the body of evidence that would make the case for FDA approval.
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