Tramadol IV Opioid Gets Negative Vote From US FDA Advisory Panel
Executive Summary
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.
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Avenue Therapeutics seems unlikely to get advisory committee support for its opioid analgesic over the agency’s conclusion that the drug’s ‘minimal benefit’ is outweighed by a potential risk from its delayed onset of pain relief. FDA has issued two complete response letters and denied Avenue’s first request for a formal dispute resolution.