Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol [Yahoo! Finance]
Avenue Therapeutics, Inc. (ATXI)
Last avenue therapeutics, inc. earnings: 8/14 07:30 am
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Source: Yahoo! Finance
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. “We have worked collaboratively with the FDA over the last year to design a study that will address a theoretical safety risk. We are pleased with the agreed-upon plan for the clinical trial and believe that this trial will support a safe profile for IV tramadol administration for acute pain in the post-operative period,” said Alexandra MacLean, M.D., Chief Execut
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ATXI
Sec Filings
- 4/26/24 - Form 8-K
- 4/17/24 - Form 4
- 4/17/24 - Form SC
- ATXI's page on the SEC website