Avenue Therapeutics, Inc. (NASDAQ: ATXI) ("Avenue"), a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol, today announced that its second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery. In addition, the trial met all of its key secondary endpoints. The study also includes a standardof-care IV opioid as an active comparator: IV morphine 4 mg. In this study, IV tramadol also demonstrated similar efficacy and safety to that of IV morphine.
"The strong safety and efficacy results from this second Phase 3 trial are consistent with those from the first Phase 3 trial in bunionectomy surgery and demonstrated the utility of IV tramadol in post-surgical pain management regardless of the surgery type," said Lucy Lu, M.D., Avenue's President and Chief Executive Officer. "This study is a significant milestone for Avenue because it brings us one step closer to submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), currently planned for year-end 2019."
"IV tramadol may fill a gap between non-opioid medicine and Schedule II opioids in the post-surgical setting and has the potential to provide a convenient bridge to the widely prescribed oral tramadol, a Schedule IV opioid," said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research and a thought leader of acute pain trials. "The results from the study demonstrated that IV tramadol is similarly potent to a conventional opioid in patients with post-surgical pain, and therefore, it could be a very important addition to the post-surgical pain armamentarium."
"We are pleased with these results," said Dr. Jaideep Gogtay, Chief Medical Officer at Cipla Limited and a board member of Avenue. "We look forward to working with Avenue in bringing a new and useful therapeutic option to U.S. patients suffering from acute pain."
Phase 3 Trial Design and Results
The Phase 3 multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 370 patients following abdominoplasty surgery. Patients were randomized in a 3:3:2 ratio to a postoperative regimen of 50 mg of IV tramadol, placebo, or 4 mg of IV morphine at hours 0, 2, 4 and once every 4 hours thereafter, respectively, for up to 13 doses over the course of 48 hours. Morphine, a standard-of-care analgesic, was included to obtain comparative safety data versus IV Tramadol.
The primary efficacy endpoint of the study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID24. The key secondary efficacy endpoints included Patient Global Assessment at 24 hours (PGA 24), SPID48, and total consumption of rescue medicine through 24 hours. A key safety objective of the study was to compare the safety and tolerability of IV tramadol to IV morphine.
IV tramadol 50 mg achieved the primary endpoint of statistically superior improvement in pain relief as measured by the SPID24 (p<0.001) compared to placebo, as well as met all three key secondary endpoints (each statistically significant at p < 0.001). IV tramadol and IV morphine demonstrated similar efficacy benefits in the study.
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