Topline results the first pivotal phase 3 clinical trial of intravenous (IV) tramadol (Avenue Therapeutics, New York, NY) have been released. Enrolled patients were randomized into 1 of 3 regimens: 50 mg of IV tramadol, 25 mg of IV tramadol, or placebo administered over 15 minutes at postoperative hours 0, 2, 4 and every 4 hours thereafter, for up to 13 doses. Patients who received IV tramadol 50 mg had a statistically superior improvement in the Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo (P = .005) and results were seen as quickly as 30 minutes after dosing. There were no reports of drug-related serious adverse events in the trial. A clear dose response was observed. This trial was carried out in patients with moderate to moderately severe postoperative pain following bunionectomy surgery. A second pivotal phase 3 trial of IV tramadol for treatment of pain following abdominoplasty surgery is planned for the third quarter of 2018.
Scott Reines, M.D., Ph.D., Avenue’s Chief Medical Officer said, “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. “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.”Next Story