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Monday, October 15, 2018

=AcelRx Pharmaceuticals (ACRX) : opioid painkiller DSUVIA to be approved by FDA


  • AcelRx confirms FDA Advisory Committee voted 10-3 in favor of recommending the approval of DSUVIA for the treatment of moderate-to-severe acute pain in adult patients



FDA staff had said the company's opioid painkiller was safe and effective for use based on resubmitted data. An advisory panel to the FDA will vote on the drug on Friday, before the regulator’s final decision by Nov 3. The staff reviewers are still concerned over the risk of accidental exposure due to misplaced tablets. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee is evaluating the company's new drug application for Dsuvia. The committee said the dosage regimen appear effective in the drug's proposed population and reasonably safe in the context of existing opioid therapy.

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