Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years.
The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.
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, which might allow the agency to turn down future applications for new opioid approvals.
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Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. The medication, which comes in a single-use package, also should not be used for more than 72 hours.
In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders.
Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg.
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In approving the drug, the agency skirted its normal vetting process, these critics say. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record a year ago with 72,000 deaths - about 200 per day.
The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval. 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.
"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. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
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More: Drugs kill more Americans than guns, cars and AIDS. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.