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FDA Should Reject Dangerous, Highly Potent Opioid Treatment

Oct. 11, 2018

FDA Should Reject Dangerous, Highly Potent Opioid Treatment

Public Citizen’s Dr. Meena Aladdin to Testify Against Sublingual Sufentanil Before FDA Panel

The U.S. Food and Drug Administration (FDA) is considering approving a new opioid medication that is five to 10 times more potent than fentanyl for the treatment of moderate-to-severe acute pain in a medically supervised setting. Dr. Meena Aladdin, a health researcher with Public Citizen’s Health Research Group, will testify today in front of the FDA’s Anesthetic and Analgesic Drug Advisory Committee and will urge the panel to recommend that the agency not approve the medication, known as sufentanil sublingual tablet.

The drug, developed by AcelRx Pharmaceuticals, does not offer any unique advantages over the numerous available FDA-approved opioid products for treating acute pain, and thus does not fill any unmet medical need. However, it does pose unique risks of serious harm if it’s misused or abused or if accidental exposure occurs.

Aladdin will tell the committee that consistent with the critical public health concept of the precautionary principle, the lack of any unique benefit and the unmitigated concern for unique risks mandate that the FDA reject this dangerous opioid.

Read her testimony.