Avenue Therapeutics to present Phase 3 bunionectomy study of IV Tramadol
Avenue Therapeutics announced an eAbstract presentation at ANESTHESIOLOGY 2019, the Annual Meeting of the American Society of Anesthesiologists in Orlando, FL. The eAbstract entitled "Tramadol Hydrochloride Injection: Effective Relief of Postsurgical Pain in Patients Undergoing Bunionectomy Surgery", is scheduled to be presented on Sunday, October 20th. The eAbstract will highlight the Phase 3 data for IV tramadol in the management of post-surgical pain in patients undergoing bunionectomy, an orthopedic model. This Phase 3, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 409 patients following bunionectomy surgery. Patients were randomized in a 1:1:1 ratio to a postoperative regimen of 50 mg of IV tramadol, 25 mg of IV tramadol or placebo administered over 15 minutes at hours 0, 2, 4 and once every 4 hours thereafter, for up to 13 doses. The primary endpoint of the bunionectomy study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID48. The key secondary endpoints included SPID24, total consumption of rescue medicine and Patient Global Assessment, which captures the patient's perception of the treatment. As previously announced, IV tramadol 50 mg met the primary as well as all of the key secondary endpoints.