Avenue Therapeutics, Inc. announced positive topline results from a second phase 3 trial evaluating the safety and efficacy of intravenous (IV) tramadol for the management of postoperative pain following abdominoplasty surgery.
The phase 3 double-blind, placebo-controlled trial involved 370 patients that were randomized in a 3:3:2 ratio to a postoperative regimen of IV tramadol 50mg, placebo, or IV morphine 4mg at hours 0, 2, 4 and once every 4 hours thereafter, respectively, for up to 13 doses over the course of 48 hours; IV morphine was included to obtain comparative safety and tolerability data compared with IV tramadol. The primary endpoint of the study was analgesic efficacy as measured by Sum of Pain Intensity Difference over 24 hours (SPID24); secondary endpoints included Patient Global Assessment at 24 hours (PGA 24), SPID48, and total consumption of rescue medicine through 24 hours.
Results of the study showed that compared with placebo, patients treated with IV tramadol 50mg had a statistically superior improvement in pain relief as measured by SPID24 (P <.001); all 3 key secondary endpoints were also met (each at P <.001). Moreover, tramadol IV demonstrated similar efficacy and safety benefits to that of morphine IV.
“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, MD, 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 US Food and Drug Administration (FDA), currently planned for year-end 2019.”
Regarding safety, IV tramadol was generally well-tolerated. The most common adverse reactions were nausea, vomiting, headache and dizziness.
Currently, there is no parenteral formulation of tramadol available in the US.
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