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Gottlieb justifies approval of Dsuvia, a new opioid

November 2, 2018 7:25 PM UTC

In the wake of calls for FDA to reject a new opioid analgesic, Commissioner Scott Gottlieb Friday explained the agency’s decision to approve Dsuvia sufentanil sublingual tablet by detailing the niche the drug fills and the additional steps the agency plans to take to address the opioid epidemic.

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 on Oct. 19 that the benefit-risk profile of Dsuvia from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supported its approval. Following the vote, the committee Chairman Raeford Brown told ABC television and other media that he opposed approval because he believes Dsuvia could be diverted and abused. Brown is a professor of anesthesiology and pediatrics at the University of Kentucky and chair of the section on anesthesiology and pain medicine at the American Academy of Pediatrics...