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