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Food and Drug Administration Commissioner Scott Gottlieb testified before a House subcommittee in May. Strict restrictions are placed on the distribution and use of Dsuvia, Gottlieb said Friday about the FDA's approval of the new opioid. But critics of the FDA's decision say the drug is useless.
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Puce Somodevilla / Getty Images
Food and Drug Administration Commissioner Scott Gottlieb testified before a House subcommittee in May. Strict restrictions are placed on the distribution and use of Dsuvia, Gottlieb said Friday about the FDA's approval of the new opioid. But critics of the FDA's decision say the drug is useless.
Puce Somodevilla / Getty Images
The Food and Drug Administration has approved a powerful new opioid painkiller, despite warnings from critical doctors that it says the drug will contribute to the addiction epidemic.
Dsuvia, a 3 millimeter wide sufentanil tablet manufactured by AcelRx, was presented to an FDA advisory committee on October 12. Such committees address the safety and efficacy of the proposed products, and the FDA generally follows the direction of its committee with respect to its decisions. drug addicts. The FDA's Anesthetic and Analgesic Drugs Advisory Committee voted 10 to 3 to recommend the drug's approval, and the agency approved the drug on Friday.
"There are very strict restrictions on the distribution and use of this product," FDA Commissioner Scott Gottlieb said Friday about his Dsuvia agency's approval. "We have learned a lot from the damaging impact that other opioid oral products may have in the context of the opioid crisis, and we have applied these difficult lessons as part of the steps we are taking to address the concerns. in the security of Dsuvia. "
But virulent critics, including the FDA's advisory committee chairman and consumer advocacy group Public Citizen, had urged the FDA to dismiss Dsuvia.
In approving the drug, the agency ignored its normal validation process, according to these critics. Dsuvia is a useless opioid, they say, and its size and power will appeal to anyone looking to sell or abuse it.
"We have worked diligently over the past three or four years to improve public health and reduce the number of powerful opioids on the street," said Dr. Raeford Brown, an anesthesiologist at the University. from Kentucky and Chairman of the FDA Committee who, despite his disagreement, voted for approval. "I do not think it will help us in any way."
Dr. Pamela Palmer, an anesthetist and co-founder of AcelRx, says that the risk of diversion – when drugs lead to people who are not the intended patients – is low with Dsuvia because it will not be administered to patients in pharmacies. Instead, health care providers will only be able to use it in medical centers, she says, and few people misuse drugs in these facilities.
"This will not contribute to the major outpatient opioid crisis," said Palmer..
While sufentanil is potent, the dose in Dsuvia is low and pre-measured: 30 micrograms, or millionths of a gram. And Palmer says the product meets a unique need – healthcare providers place it under patients' tongue, rather than injecting it or giving them a pill to swallow, which she says may take too much time to bring relief.
"If you want to quickly defeat someone's pain, you have to choose a different path from that of swallowing a pill," Palmer said. She is considering the use of the tablet by providers when looking for a vein is difficult and urgent – in patients with obese emergency rooms for example, morbidly obese.
The company expects annual sales of $ 1.1 billion and hopes to have its product in hospitals early next year.
Palmer also said that the Department of Defense had helped fund the company's research because Dsuvia could potentially be used on the battlefield instead of morphine.
Dr. Sidney Wolfe, Senior Advisor for the Public Citizen Health Research Group, rejects Palmer's assertion that Dsuvia is addressing a critical need. The group sent a letter to the FDA with Brown expressing concerns about the drug.
"This is not unique at all," said Wolfe, adding that the drug had not been adequately tested in emergency situations and that, during tests , the pain relief with Dsuvia had been slow. In two of the company's studies, Dsuvia patients experienced "significant" pain relief only after 54 minutes and 78 minutes.
"We can find a niche for [Dsuvia] but it's not like we need it, and it's certain that at some point it's going to be diverted, "says Dr. Palmer MacKie, an assistant professor at the Indiana School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. "Do we really want an opportunity to divert another medicine?"
Although the advisory committee ultimately voted in favor of the drug, Public Citizen says the FDA has sought to "tip" the vote result toward approval. Brown, the committee's chief, who has been openly voicing some opioids in the past, said he had not been able to attend the Oct. 12 advisory committee meeting due to 39; a time conflict which he had informed the FDA several months in advance.
Brown says the FDA has decided to hold the meeting anyway – without him.
"I am very attached to the opioid crisis as a citizen of the Commonwealth of Kentucky, where people continue to die," said Brown. "My frank nature may have played a role in their decision as to how the agency would manage this advisory board."
The October meeting also left out most of the members of another FDA committee – the Drug Safety Advisory Committee and Risk Management – who often participate in discussions on new opioid drugs. Public Citizen says that members of this committee have not been invited to attend.
In an email, An FDA spokesperson wrote that members of the drug safety committee "could not attend because of scheduling conflicts".
"This is not the complete story," Brown said.
On Wednesday, prior to the FDA's final decision, four US senators – Ed Markey, Claire McCaskill, Joe Manchin and Richard Blumenthal – were sent. a letter to Gottlieb, the FDA Commissioner, echoing the concerns of Brown and Public Citizen and asking the agency to deny approval to Dsuvia until Brown and the committee of safety of the complete drug be allowed to participate. In the end, the FDA still approved the drug.
"There should never be a meeting on opioids again without drug safety," said Wolfe. "The FDA really messed up."
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