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sufentanil (DSUVIA)

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Additional Information from Public Citizen

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    In a letter to Dr. Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, Public Citizen and the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee explain how the Commissioner misled the public regarding potential “unique” benefits of Dsuvia, a controversial, highly potent opioid pain relief medication.
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    In a joint op-ed, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and Dr. Raeford Brown, chair of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, are highly critical of the FDA’s reckless decision to approve sufentanil sublingual tablets, a new opioid that will be sold under the brand name Dsuvia.
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    The Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid, Public Citizen and the head of a key FDA advisory committee said today. The FDA gave the green light for the medication, which is called sufentanil sublingual tablet (brand name Dsuvia) and is to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.
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    In a letter to the FDA, the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee joined three Public Citizen experts in urging the agency to reject Acer Pharmaceuticals’ new drug application for sufentanil sublingual tablets for treatment of moderate-to-severe acute pain in a medically supervised setting. This opioid, which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine, would be abused and start killing people as soon as it hits the market.
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    In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by AcelRx Pharmaceuticals for sufentanil sublingual tablets because the drug is a dangerous, high potency opioid that does not provide any unique advantages over currently available opioids, but does pose unique risks.

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