FDA Approves Phase 3 Safety Study Protocol for Avenue's IV Tramadol

Avenue Therapeutics, a company dedicated to developing and commercializing treatments for neurological disorders, has finalized a Phase 3 safety study protocol with the FDA for intravenous (IV) tramadol. The study aims to evaluate the potential risk of respiratory depression associated with opioid stacking when IV tramadol is used for acute post-operative pain management. The research will involve approximately 300 patients who have undergone bunionectomy surgery, randomly assigned to receive either IV tramadol or IV morphine for pain relief over a 48-hour period post-operation.

The primary endpoint of the study will focus on a composite of indicators that suggest respiratory depression. The company is optimistic that the trial can be completed within a year and submitted to the FDA to address a Complete Response Letter (CRL), which could lead to the approval of IV tramadol. Access to IV hydromorphone, a Schedule II opioid, will be provided for patients experiencing breakthrough pain.

Avenue Therapeutics' CEO, Dr. Alexandra MacLean, expressed satisfaction with the collaborative effort with the FDA and the agreed-upon plan for the clinical trial. She believes that the trial will support the safety profile of IV tramadol for acute post-operative pain management. The company is planning to initiate the Phase 3 safety study as soon as possible, subject to securing the necessary financing, which could come through a strategic partnership. Dr. MacLean anticipates that positive study results could lead to FDA approval, potentially improving treatment options for managing post-operative pain in the U.S. and providing value to the company's shareholders.

The company is also developing other assets, including AJ201 for spinal and bulbar muscular atrophy, BAER101 for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for managing acute postoperative pain in adults in medically supervised settings. Avenue Therapeutics is based in Miami, Florida, and was founded by Fortress Biotech, Inc.