Outcome of FDA Advisory Committee Meeting on IV Tramadol
Avenue Therapeutics, Inc. a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, announced the outcome of the FDA joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.
In the final part of the public meeting, the Advisory Committee voted yes or no on the following question: “Has the Applicant submitted adequate information to support the position that the benefits of their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting?” The results are 8 yes votes and 14 no votes.
FDA Advisory Committees provide the FDA with independent advice and non-binding recommendations. The FDA has previously stated that input from an Advisory Committee is needed for the Office of New Drugs ("OND") to reach a decision on Avenue’s formal dispute resolution request and that the OND will respond to Avenue’s FDRR within 30 calendar days after the Advisory Committee meeting.
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