Avenue Therapeutics Reaches Deal With FDA For Phase 3 Safety Study For IV Tramadol

(RTTNews) - Specialty pharmaceutical company Avenue Therapeutics, Inc. (ATXI) announced Thursday that it has reached final agreement with the U.S. Food and Drug Administration on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol

Tramadol 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.

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. IV tramadol demonstrated safety and efficacy in this same surgical model in two Phase 3 efficacy trials.

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.