Avenue therapeutics announces agreement with the fda on the study design and analysis approach of the phase 3 safety study for iv tramadol

Miami, july 25, 2023 (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 agreement with the u.s. food and drug administration (“fda”) on key elements of the phase 3 safety study, including the primary endpoint and statistical analysis approach, for intravenous (iv) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. the agreed upon 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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