Avenue Therapeutics Announces Dosing of First Patient in Second Pivotal Phase 3 Clinical Trial

Avenue Therapeutics (NASDAQ:ATXI) a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol, today announced that the first patient has been dosed in a pivotal Phase 3 clinical trial of IV tramadol for the management of moderate to moderately severe pain in patients following abdominoplasty surgery.

As quoted in the press release:

“The commencement of the Phase 3 abdominoplasty study is a key step in the advancement of the clinical development for IV tramadol. This study not only compares the efficacy and safety of IV tramadol to placebo, but also compares the safety and tolerability of IV tramadol to an active comparator (IV morphine),” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “This is an important aspect of the study, because IV tramadol, if approved, will be used in the hospital setting where IV opioids are already being used and it may be a better alternative for many patients.”

The Phase 3, multicenter, randomized, double-blind, three-arm trial will evaluate the efficacy and safety of IV tramadol 50 mg versus placebo. Approximately 360 patients will be enrolled to IV tramadol 50 mg, placebo or morphine in a 3:3:2 ratio. The primary efficacy endpoint is the summed pain intensity difference over 24 hours (SPID24) compared to placebo. Additional information on the study can be found on www.clinicaltrials.gov using the identifier NCT03774836.

Click here to read the full press release.