Despite the lives destroyed from addiction and the rising death toll, on Friday the FDA approved a new opioid medication five to 10 times more powerful than fentanyl. It is expected to be available in the first quarter of next year. (This drug is already available as an IV medication (its chemical name is sufentanil) so this newly approved form will be a better “option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill.”1)
Made by AcelRx Pharmaceuticals Inc., Dsuvia, “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.”2
Despite telling CNN Medical Correspondent Dr. Sanjay Gupta, back in April, that opioids are “the biggest crisis facing the nation” FDA Commissioner Dr. Scott Gottlieb defended the new dangerous drugs approval saying, “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.”3
Every year in the US more people die from drug overdoses than from breast cancer.
He went on to say,
“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.”4
Something the critics disagree with. Public advocacy group Public Citizen said, “The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid”5 and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group said, “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly.”6
Agreed. Because people.
And greed.
And addiction.
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I say that because DSUVIA is not supposed to be available in pharmacies or for outpatient use. Rather, it will only be distributed in health care settings that have been certified in the “DSUVIA Risk Evaluation and Mitigation Strategy (REMS)” program. And, according to the FDA, it will not only come with a black box warning but cannot be used for more than 72 hours.
But we shall see.
Here’s Gottlieb again,
“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.”7
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(It should also be mentioned here that the Department of Defense was involved in the development of this drug and that it was a priority for the Pentagon because of the unmet need it fills. Also, see the above article.)
This decision by the FDA seems to be wildly unwise.
We will continue to watch as this situation unfolds and hope that things don’t spin out of control.
