Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results

Publication highlights IV tramadol 50 mg demonstrated a statistically significant benefit (p-value < 0.05) over placebo for primary and all key secondary efficacy endpoints

NEW YORK, July 21, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that the results from its Phase 3 study of IV tramadol in patients undergoing bunionectomy have been published in the peer-reviewed journal, Pain and Therapy.

The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg or placebo.  The primary endpoint was the summary of pain intensity differences (“SPID”) over 48 hours.  Key secondary endpoints included SPID over 24 hours, total consumption of rescue analgesia, and patient global assessment of efficacy.  Safety assessments included treatment emergent adverse events (“TEAEs”), clinical laboratory tests, vital signs, and electrocardiograms (“ECG”).  Assessment of the dose-response was an important objective of the study. The study established a clear dose response, with IV tramadol 50 mg demonstrating a statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas IV tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. IV tramadol 50 mg was well-tolerated.  The most common TEAEs were nausea and vomiting, and there were no meaningful differences among the treatments for vital signs, ECG, and laboratory assessments. The largest proportion of patients completed IV tramadol 50 mg (98.6%) compared to IV tramadol 25 mg (91.8%) and placebo (88.2%). The study concluded that IV tramadol 50 mg was effective and well-tolerated as a treatment for postoperative pain following bunionectomy surgery, while IV tramadol 25 mg, although well-tolerated, was judged to be an ineffective dose for the treatment of pain in this setting.