Avenue Therapeutics (NASDAQ: ATXI)'s second Phase 3 trial of IV tramadol for the treatment of postoperative pain following abdominoplasty is a success.
The announcement said the trial met all of its key secondary endpoints. The study also includes a standard-of-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 CEO Lucy Lu in a press release. “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."
Avenue Therapeutics is trading up 10.3 percent at $5.74 per share Monday afternoon. The stock soared as high as 30 percent earlier in the day.
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