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FDA Approves Controversial New Opioid

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FDA Approves Controversial New Opioid

U.S. Sen. Edward J. Markey sharply criticized an FDA advisory committee’s vote to approve Dsuvia last month. It is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, he warned.

The U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision. In it, he repeatedly cited its usefulness on battlefields to treat wounded soldiers.

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” he wrote. “The military application for this new medicine was carefully considered in this case. We understand the concerns about the availability of a high potency formulation of sufentanil and the associated risks. The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield.”

Dsuvia, made by a company named AcelRx, is a tablet form of sufentanil that is meant to be dissolved under a patient’s tongue. It is delivered through a disposable, pre-filled, single-dose applicator. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional.

Last month, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that Dsuvia be approved. But U.S. Sen. Edward J. Markey, D-Mass., sharply criticized that vote, saying Dsuvia is an opioid painkiller up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said.

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