Proposed therapy is five to 10 times more potent than fentanyl . . .

FDA Panel Supports Approval Of Sufentanil Drug; Expert Calls It ‘Baffling’

By Beth Wang / October 16, 2018 at 4:11 PM
An FDA advisory committee on Friday (Oct. 12) determined that the benefits of a proposed new sufentanil sublingual tablet support the product's approval, overriding three panel members who disagreed. The tablet, a drug-device combination that is five to 10 times more potent than fentanyl, is the first product proposed for acute pain severe enough to require an opioid analgesic, according to a memo FDA sent to its advisory committee members in September. FDA had rejected the product a year ago,...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.