Avenue Therapeutics Shares Rise 68% After FDA Agreement for Tramadol Study
04 January 2024 - 3:29PM
Dow Jones News
By Chris Wack
Avenue Therapeutics shares were up 68% to 29 cents after the
company reached final agreement with the U.S. Food and Drug
Administration on the Phase 3 safety study protocol and statistical
analysis approach, including the primary endpoint, for intravenous
tramadol.
The specialty pharmaceutical company said the study is for the
treatment of acute post-operative pain in a medically supervised
setting.
The final non-inferiority study is designed to assess the
theoretical risk of opioid-induced respiratory depression related
to opioid stacking on IV tramadol compared with IV morphine.
The study will randomize 300 post bunionectomy patients to IV
tramadol or IV morphine for pain relief administered during a
48-hour post-operative period. IV tramadol demonstrated safety and
efficacy in this same surgical model in two Phase 3 efficacy
trials.
Avenue believes the study can be completed within 12 months and
potentially lead to approval of IV tramadol.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 04, 2024 10:14 ET (15:14 GMT)
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