Avenue Therapeutics Announces Positive Topline Phase 3 Data for Intravenous Tramadol in the Management of Postoperative Pain

On May 22, 2018

Avenue Therapeutics announced that its first pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo in patients with moderate to moderately severe postoperative pain following bunionectomy surgery. In addition, the trial met its key secondary endpoints and demonstrated a clear dose response. Avenue plans to initiate a second pivotal Phase 3 trial of IV tramadol in patients following abdominoplasty surgery in the third quarter of 2018.

“There is a clear need for new therapies in the postoperative pain setting, where patients are often treated with Schedule II narcotics due to a lack of other options,” said Harold Minkowitz, M.D., an investigator in IV tramadol’s Phase 3 program. “IV tramadol, which acts by a dual mechanism, is widely used outside the U.S. in the postoperative setting. These Phase 3 results demonstrate that IV tramadol is well tolerated and rapidly and effectively induces pain relief in patients following bunionectomy surgery, a generally painful procedure, and suggest that IV tramadol could be an important new therapy for managing postoperative pain in our patients.”

“We are greatly encouraged by the strong safety and efficacy results from our first Phase 3 trial, which support IV tramadol’s potential to provide an improved IV treatment option for postsurgical pain, and to fill a significant gap between IV NSAIDs and Schedule II opioids,” said Scott Reines, M.D., Ph.D., Avenue’s Chief Medical Officer. “Moreover, the trial clearly defined the 50 mg dose that will be applied in our second Phase 3 trial in patients following abdominoplasty surgery as well as in our ongoing safety trial.”

“IV tramadol has the potential to provide a convenient bridge to the widely prescribed oral tramadol. This combination could displace Schedule II narcotics altogether for many patients, and provide a treatment option with less potential for abuse and a lower risk of dependence,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We are excited about these results and look forward to initiating a second pivotal Phase 3 trial in the third quarter and, assuming positive data from that study and our ongoing safety trial, we anticipate filing an NDA with the U.S. Food and Drug Administration in late 2019.”