Dsuvia: A Dull US FDA Review Preceded The Controversial Approval

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

Drug Review Profile regular column

The US Food and Drug Administration's approval of AcelRx Pharmaceuticals Inc.'s Dsuvia (sufentanil sublingual) ignited a wave of backlash against the agency, with critics questioning whether the US market needs another opioid amid an epidemic and suggesting the agency was influenced by the Department of Defense's desire to see the drug approved.

But it appears that all of the fireworks surrounding the approval were generated externally. The FDA's review documents paint a...

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