FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Defends FDA’s Approach to New Opioids After Dsuvia Approval

Nov. 30, 2018
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FDA Commissioner Scott Gottlieb defended the FDA’s approval of a powerful opioid that  critics say is more addictive and susceptible to diversion than fentanyl — and said the agency plans to consider the merits of any new drug along with efforts to address the opioid epidemic.

The agency approved AcelRx’s Dsuvia, a sublingual formulation of sufentanil that is many times more potent than fentanyl, despite opposition from the chair of the FDA advisory committee that recommended the drug.

The FDA’s Anesthetic and Analgesics Advisory Committee voted 10-3 on Oct. 12 that the benefits of Dsuvia outweigh its risks for treating moderate-to-severe acute pain, but the panel was not asked to vote on the drug’s safety or abuse potential.

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