FDA Approves Controversial New Opioid


On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved a new sublingual formulation and delivery system of the synthetic opioid sufentanil for managing moderate-to-severe acute pain in adults who are in medically supervised settings, such as hospitals, surgical centers, and emergency departments.

Dsuvia is 10 times more powerful than fentanyl.

The new, single-dose tablet version of the pain killer, mean to be taken under the tongue, can only be given in hospitals and is meant for those who can't take an IV.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.

The medication should not be used for more than 72 hours at a time, according to the FDA.

Can the drug be prevented from being abused and misused?

In approving the drug, the agency skirted its normal vetting process, these critics say.

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The company producing Dsuvia, AcelRx, argued it would be an "important non-invasive, rapidly acting alternative to IV opioids".

Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.

The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month. In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers".

"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. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies.

In a statement issued Friday, the group contended that, "if approved, Dsuvia will be abused and start killing people as soon as it hits the market".

The statement noted the benefit the drug could have for soldiers injured on the battlefield. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb wrote. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.