FDA approves new opioid more potent than fentanyl
WASHINGTON — The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.
The drug is five to 10 times more potent than pharmaceutical fentanyl. The pill, just three millimeters in diameter, is likely to worsen the nation’s drug crisis, according to critics and the head of the FDA’s advisory committee on painkillers.
At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need.
“We need to address the question that I believe underlies the criticism raised in advance of this approval,” Gottlieb wrote. “To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider ... the epidemic of opioid misuse and abuse that’s gripping our nation?”
As the worst drug crisis in U.S. history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA’s practice of evaluating each opioid application on its own.
Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic — which killed a record 49,000 users in 2017, according to preliminary data — with the needs of people who need strong pain relief. But Friday’s statement is the first detailed indication of how the FDA might use its drugreview process to tackle the overall problem.
Gottlieb said he would bring a plan to the FDA’s Opioid Policy Steering Com- mittee and perhaps Congress. The guidelines would allow the agency to consider a narcotic’s benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.
“In this way, (drug companies) would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness,” he wrote.
The drug approved Friday is a 30microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms. Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine.
The drug is intended for use within health care settings and perhaps on the battlefield. It would not be available in retail pharmacies.
The manufacturer, a California company called AcelRx, will market the drug in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.
AcelRx aready has approval for 15- and 30-microgram versions of the drug in Europe.
An FDA advisory committee recommended approval of the new drug in a 10-3 vote Oct. 12. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Sidney Wolfe, founder of Public Citizen’s Health Research Group, said in a statement.
Including brand name and generic drugs, there are nearly 400 opioids on the market.