FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Public Citizen Pushes Back on Claims Dsuvia Could Benefit Soldiers

Dec. 20, 2018

Public Citizen challenged the FDA’s approval of AcelRX’s powerful opioid Dsuvia (sufentanil sublingual tablet), arguing in a letter sent Tuesday to Commissioner Scott Gottlieb that the drug will not serve its intended purpose of treating wounded soldiers.

The FDA approved the drug in November for moderate to severe acute pain in medically supervised settings. Critics of the decision point out that the drug is many times more potent than fentanyl.

Public Citizen questioned Gottlieb’s claim that the drug could help treat soldiers in battlefield settings, noting that the clinical trials only involved patients who underwent minor surgical procedures.

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