Avenue Therapeutics Shares Rise 68% After FDA Agreement for Tramadol Study

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 [e-mail]

(END) Dow Jones Newswires

01-04-24 1014ET