FDA Approves New Opioid Opposed by Markey and Others

Regulatory NewsRegulatory News
| 02 November 2018 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Friday approved a new opioid, AcelRx Pharmaceuticals’ Dsuvia (sufentanil sublingual tablet), despite objections from Sen. Ed Markey (D-MA), Public Citizen and the chair of the advisory committee that reviewed the medicine. The agency also sent a complete response letter for Trevena’s New Drug Application (NDA) for the pain medicine oliceridine.
In explaining the approval FDA Commissioner Scott Gottlieb said that Dsuvia, also approved in Europe last July, 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.
He noted the drug “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.”
He also stressed the importance of context in the decision, and given the other opioid analgesics already on the market, the epidemic of opioid misuse and abuse that’s gripping our nation and the risk for illicit diversion and abuse.
“I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium,” Gottlieb added.
FDA is "recklessly and needlessly endangering people" by approving the opioid, Public Citizen and the head of a key FDA advisory committee said Friday.

"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,” said Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group.

Last month, a letter (PDF) was sent to FDA from Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, and Public Citizen, calling on the agency to reject the approval of Dsuvia.
Brown also raised questions about the potential for abuse.
“It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” Brown wrote. “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.”
Similarly, Public Citizen said that Dsuvia is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. It will be abused, the group said, and start killing people as soon as it hits the market.
Markey added: “Even in the midst of the worst drug crisis our nation has ever seen, the FDA once again is going out of its way to approve a new super-charged painkiller that would only worsen the opioid epidemic. It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts.”


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