Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol

MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq:ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

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