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Avenue Therapeutics, Inc.

Latest From Avenue Therapeutics, Inc.

US FDA Advisory Committees As The Court Of Appeals

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

Advisory Committees Drug Review

Tramadol IV Opioid Gets Negative Vote From US FDA Advisory Panel

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.

Advisory Committees Drug Safety

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.

Advisory Committees Clinical Trials

The Politics Of US FDA Advisory Committees

FDA has a series of potentially high-profile advisory committees lined up to kick off 2022. One key underlying theme: whether and when the agency should use advisory committees to combat the perception of undue political pressure.

Advisory Committees Politics
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