Delayed Onset Of Tramadol IV Creates Risk Of ‘Opioid Stacking,’ US FDA Finds
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.
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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.
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.
Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.