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.

"An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill," he said Oct. 18. "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. It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts. I call on the FDA to reject the vote of the advisory committee and stop the approval of this dangerously unnecessary opioid medication."

Gottlieb argued there are "very tight restrictions being placed on the distribution and use of this product. We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis," he added. "We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia."

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