Avenue Therapeutics reaches final agreement with the FDA for the phase III safety study for IV Tramadol.

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 Executive Officer of Avenue.

The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in two Phase III efficacy trials. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression. Avenue believes the study can be completed within 12 months and submitted to the FDA to address the CRL and potentially lead to approval of IV tramadol.

Dr. MacLean continued, “Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate the Phase III safety study as soon as possible, and could potentially have study results in-hand as early as the end of this year. We expect that a positive study outcome could result in the FDA approval of IV tramadol, potentially improving the current treatment paradigm available for U.S. patients in managing post-operative pain and providing significant near-term value for Avenue shareholders.”