A New Drug 10X Stronger Than Fentanyl? FDA Says OK

Amid deepening addiction crisis, FDA approves potent new opioid

| CNN – 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.

Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers, and emergency rooms, according to the company.

FDA Commissioner Dr. Scott Gottlieb was quick to defend the approval in a statement Friday:

“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.”

In April, Gottlieb told CNN that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. The numbers say it all: More people die in the US each year from drug overdoses than from breast cancer.

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Following the approval of Dsuvia, Gottlieb acknowledged that opioids are a unique class of medications:

“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. 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.”

But the criticism was quick. “The [FDA] is recklessly and needlessly endangering people by approving a super-strong opioid,” a statement from the public advocacy group Public Citizen said.

The group noted that Dsuvia is five to 10 times more powerful than fentanyl and 1,000 times more potent than morphine.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe … Read more. 

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