05:57 GMT24 July 2021
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    The US Food and Drug Administration (FDA) on Friday approved a powerful new opioid to use in care settings despite criticism from one of its own advisers.

    FDA Commissioner Scott Gottlieb issued a special statement on the approval of the new drug, Dsuvia, noting that its use will be strictly controlled and that the agency understands the controversy behind its decision, the Washington Post reported.

    READ MORE: Trump Says Foreign Pharma Companies Responsible for Rigging US Drug Prices

    “It fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said, noting that the drug will be sold in the form of a 30-microgram tablet designed to be put under the tongue, making it more suitable for battlefield situations where people cannot easily inject a drug.

    Gottlieb also noted that the drug will only be authorized for use by professionals in healthcare settings and possibly on battlefields, so patients will not be able to get it at a pharmacy and take it home. Dsuvia is reportedly 10 times more powerful than fentanyl and 1,000 times more powerful than morphine. It was developed by manufacturer AcelRx in cooperation with the Pentagon, which spent millions of dollars on the project.

    Public Citizen, a consumer rights advocacy group, objected to Dsuvia’s approval, as did Raeford Brown, the chairman of the FDA advisory committee, who wasn’t present during the vote regarding the drug.

    “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die,” Sidney Wolfe, the founder of Public Citizen’s Health Research Group, said in a statement.

    Gottlieb, however, said the FDA would do more to balance efforts to fight the epidemic with the needs of people who need strong painkillers.

    “We need to address the question that I believe underlies the criticism raised in advance of this approval. 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?” Gottlieb wrote in his statement.

    The US is facing what has been called the worst drug crisis in the country’s history, with overdoses killing a record 72,000 users in 2017, according to preliminary data from the US Centers for Disease Control and Prevention. As in 2016, which had a death toll of approximately 64,000, the 2017 US death toll from drug use was higher than all US military casualties in the Vietnam and Iraq wars combined.


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    opioids, Drugs, opioid painkillers, FDA, Pentagon, US
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