• FDA committee approves AcelRx's opioid formulation

    7 monthes ago - By Healio

    By a 10-3 vote on Friday, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee said the benefits of AcelRx's Dsuvia tablet outweigh the risks for managing moderate-to-severe acute pain in adults in medically-supervised settings.
    The FDA does not have to abide by committee decisions, but historically the FDA has followed committee recommendations.
    The pill's manufacturer had been asked by the FDA in a 2017 complete response letter to provide additional data on safety, efficacy and instructions for its use.
    “Dsuvia... has a predictable onset of action of 15
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