Avenue Therapeutics Pain Management Treatment Rejected By FDA Again; Shares Drop

  • Avenue Therapeutics Inc ATXI has received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
  • Citing delayed and unpredictable onset of analgesia with tramadol, the agency said that the treatment does not support its benefit as a monotherapy to treat patients in acute pain.
  • Also, there is insufficient information supporting the safety and effectiveness of tramadol in combination with other analgesics.
  • The FDA did not identify any Chemistry, Manufacturing, and Controls issues.
  • Avenue disagrees with the FDA's interpretation of the data and intends to pursue regulatory approval for IV tramadol.
  • Price Action: ATXI shares dropped 4.8% at $4.01 before the trading was halted. To resume at 7:30 a.m. ET.
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