FDA's AdComm Says Avenue Therapeutics Submitted Insufficient Data On IV Tramadol

FDA's AdComm Says Avenue Therapeutics Submitted Insufficient Data On IV Tramadol

Avenue Therapeutics Inc ATXI announced the outcome of the FDA meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

  • The Advisory Committee had to vote on "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.
  • In June last year, Avenue Therapeutics has received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
  • Then the COmpany said it disagreed with the FDA's interpretation of the data and intends to pursue regulatory approval for IV tramadol.
  • Price Action: ATXI shares are down 44.8% at $0.31 during the premarket session on the last check Wednesday.
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