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FDA approves new controversial opioid
US Senator Edward J. Markey strongly criticized the FDA's advisory committee vote to approve Dsuvia last month. It is up to 10 times more potent than fentanyl and 1,000 times more potent than morphine, he warned.
The US Food and Drug Administration has approved the marketing of an opioid called Dsuvia. FDA Commissioner Dr. Scott Gottlieb has issued a long statement in defense of the decision. He repeatedly quotes his utility on the battlefield to treat wounded soldiers.
"The FDA is given as a priority to ensure that our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not feasible." for the treatment of acute pain related to battlefield injuries, "he wrote. "The military application of this new drug has been carefully examined in this case.We understand the concerns about the availability of a high potency formulation of sufentanil and the associated risks." The FDA has put in place a REMS that reflects the potential risks associated with this product and prescribes that Dsuvia will only be available for use in a physician-supervised and physician-controlled health facility, including on the battlefield. "
Dsuvia, manufactured by a company called AcelRx, is a form of sufentanil tablet that must be dissolved under the tongue of a patient. It is administered by a single-use, disposable, pre-filled applicator. The FDA has restricted its use to health care accredited health care facilities, such as hospitals, surgical centers and emergency services, as well as for administration by a health professional.
Last month, the FDA's Anesthetic and Analgesic Pharmaceuticals Advisory Committee voted 10 to 3 in favor of Duvia's approval. US Senator Edward J. Markey, D-Mass., Strongly criticized this vote, saying that Dsuvia was an opioid analgesic up to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The committee voted when its chair, Dr. Raeford Brown, who publicly opposed the application, was not present, and the FDA also did not invite the Drug Safety Advisory Committee and the Drug Safety Advisory Committee. risks to attend the advisory committee meeting, said Markey.
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