IV tramadol was well-tolerated with no reports of drug-related serious adverse events in the trial. One patient in the 50 mg IV tramadol arm discontinued the trial due to an adverse event (vomiting). The most common (≥5%) adverse events in the trial where IV tramadol 50 mg differed from placebo were nausea, vomiting, dizziness and somnolence.
05.21.18
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.
“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.”
The 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.
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.
“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.”
The 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.
