Fortress Biotech (NASDAQ:FBIO) partner company, Avenue Therapeutics (NASDAQ:ATXI) announced that it reached a final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for IV tramadol to treat acute post-operative pain in a medically supervised setting.
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 3 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.
“Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate the Phase 3 safety study as soon as possible, and could potentially have study results in-hand as early as the end of this year,” Dr. Alexandra MacLean, CEO of Avenue, said in a statement. “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.”