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Delayed Onset Of Tramadol IV Creates Risk Of ‘Opioid Stacking,’ US FDA Finds

 
• By Brenda Sandburg

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.

Injectable drug
US FDA advisory committee to consider new drug application for intravenous tramadol • Source: Alamy

After a lengthy back-and-forth with Avenue Therapeutics, Inc., the US Food and Drug Administration is asking its advisory committees to vote on whether the benefits of the intravenous formulation of tramadol outweigh the risks for management of acute pain in an inpatient setting. Given the agency’s concerns about the potential risks of the product and the panel’s decisions on other opioid analgesics, a no vote seems likely.

The agency has issued two complete response letters saying it could not approve Avenue’s new drug application due to the potential risk from tramadol IV’s delayed onset of analgesia

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