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FDA May Approve New Opioid That’s 5- to 10-Times Stronger Than Fentanyl

Almost half of all overdose deaths in the United States is caused by Fentanyl, according to research released earlier this summer. So it may seem surprising that the U.S. Food and Drug Administration (FDA) is considering giving approval to AcelRx Pharmaceuticals for Dsuvia, its single-dose 30 microgram tablet of synthetic opioid sufentanil. Sufentanil is five to 10 times stronger than fentanyl and 500 times stronger than morphine, according to Marketwatch.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recently voted 10-3 in favor of U.S. approval of Dsuvia. The FDA is not required to but often follows the committee’s recommendations.

But even among committee members, there is disagreement about the necessity of releasing another potent opioid to the public. Dr. Raeford Brown, the chair of the committee and a professor of anesthesiology and pediatrics at the University of Kentucky, expressed concern about Dsuvia, which he noted comes in a form that can be easily diverted—meaning someone without a prescription might still be able to access the drug. “This drug offers no advance, in my mind, over previously available opioid formulations, but provides great risk of harm to patients and the general public health,” Brown told Marketwatch in an interview.

Lawmakers have also been urging regulators to reconsider the committee’s advice. Massachusetts Senator Edward Markey, citing Dr. Brown’s skepticism, said the FDA’s consideration of this new drug “makes no sense.” In a statement, Markey noted, “Even in the midst of the worst drug crisis our nation has ever seen, the FDA once again is going out of its way to approve a new super-charged painkiller that would only worsen the opioid epidemic.

A final decision from the FDA is expected by November 3.