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Tramadol IV Opioid Gets Negative Vote From US FDA Advisory Panel

 
• By Brenda Sandburg

Joint advisory committee concludes 14 to 8 that Avenue Therapeutics’ data does not show that benefits of tramadol IV outweigh risks for acute pain management in an inpatient setting. Several panelists did not share FDA’s concern about the theoretical risk of opioid ‘stacking’ while others said delayed onset of analgesia is problematic.

Tramadol
Joint US FDA advisory committee concludes data do not show the benefits of tramadol IV outweigh its risks. • Source: Alamy

A joint US Food and Drug Administration advisory committee affirmed the agency's rejection of Avenue Therapeutics, Inc.’s new drug application for tramadol IV, but a split vote on the data reflects the disagreement over the benefit-risk assessment of the opioid analgesic and whether there is a need for another treatment option.

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