AcelRx secures US approval for sublingual opioid therapy

5 November 2018

Shares in AcelRx Pharmaceuticals (Nasdaq: ACRX) leapt 20% on Friday, after the Californian firm announced the US regulator had approved its opioid medication Dsuvia (sufentanil) for use against acute pain in a hospital setting.

The advisory panel of the US Food and Drug Administration recommended approval a few weeks ago, going against the warning of its own chairman, who wrote to the agency’s commissioner, Scott Gottlieb, urging the drug be rejected due to concerns that it could be abused.

The FDA previously declined to approve Dsuvia on these grounds, calling for more data on at least 50 patients to assess the safety of Dsuvia at the maximum amount described in the proposed labeling.

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