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Almost half of all overdose deaths in the United States is caused by Fentanyl, according to research released earlier this summer. It is surprising that the US Food and Drug Administration (FDA) is considering giving approval to AcelRx Pharmaceuticals for Dsuvia, its single-dose 30 microgram tablet of synthetic opioid sufentanil. Is 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, chair of the committee and professor of anesthesiology and pediatrics at the University of Kentucky, expressed concern about Dsuvia, which he noted comes into a form that can be easily diverted to access the drug. "This drug offers some advance, in my mind, on 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, it is going to be a new super-painkiller that would only be opioid epidemic.
A final decision from the FDA is expected by November 3.
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