FDA approves new, powerful drug amidst opioid crisis

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Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that's said to be 10 times more powerful than fentanyl.

The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it. "It can't be dispensed to patients for home use and should not be used for more than 72 hours".

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But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments.

As the worst drug crisis in USA 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. 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. The objective, 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.

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"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. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program. It is expected to be available in the first quarter of next year.

"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 related to battlefield wounds", he wrote. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

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"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.

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