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FDA approves powerful new opioid amidst overdose crisis

Dsuvia, a new medication five to 10 times more powerful than fentanyl, was approved to be prescribed to patients in hospital settings

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Dsuvia, a single-dose opioid tablet, was approved to be distributed to patients in hospital settings.

Photo/AcelRx

WASHINGTON — The Federal Drug Administration approved a powerful new opioid, despite the ongoing opioid overdose crisis.

WMUR reported that Dsuvia, a single-dose tablet that is five to 10 times more powerful than fentanyl, was approved to be distributed to patients in hospital settings, according to manufacturer AcelRx Pharmaceuticals Inc.

FDA Commissioner Dr. Scott Gottlieb defended the organization’s approval of the drug in a statement.

“The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain,” he said.

https://twitter.com/SGottliebFDA/status/1058418209714528256

“I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits,” Gottlieb continued. “We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction.”

Public advocacy group Public Citizen criticized the approval of Dsuvia.

“The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid,” the group said.

Public Citizen’s Health Research Group founder and senior adviser Dr. Sidney Wolfe said Dsuvia “will worsen the opioid epidemic and kill people needlessly.”

AcelRx stressed that Dsuvia won’t be available for outpatient use.

“Dsuvia will only be distributed to health care settings certified in the Dsuvia Risk Evaluation and Mitigation Strategy program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of Dsuvia,” the manufacturer said in a statement.

The FDA said the drug cannot be used for more than 72 hours.

“Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia,” Gottlieb said.

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