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IV Tramadol Shown Effective in New Phase 3 Trial

50 mg dose demonstrates an improvement in pain reduction

A PPM Brief

In a study of IV tramadol, Avenue Therapeutics (New York, NY) has announced1 that its first Phase 3 trial achieved statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo in patients with moderate to moderately severe post-operative pain following bunionectomy surgery.

The multicenter, double-blind, placebo-controlled trial1 evaluated the efficacy and safety of IV tramadol in 409 patients. Patients were randomized to a post-operative 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, achieved by the 50 mg treatment, assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID48. IV tramadol 50 mg achieved statistically significant improvement in pain reduction as early as one half hour after dosing.

IV tramadol was well tolerated among subjects with no reports of drug-related serious adverse events in the trial. Most adverse events were mild or moderate with only 4 (3%) of patients experiencing a Grade 3 event (vomiting).1

Detailed trial results are forthcoming, and Avenue plans to initiate a second Phase 3 trial in patients following abdominoplasty surgery in the third quarter of 2018. One of the focuses of the second trial will be on findings of a better tolerability profile than historical data of IV opioids in similar settings, discovered in this trial.1

 “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 lead investigator Harold Minkowitz, MD, in a company press release. “IV tramadol, which acts by a dual mechanism, is widely used outside the US 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.”

If approved by FDA, IV tramadol would be the first Schedule IV intravenous opioid in the US, and may provide doctors with an improved treatment option that delivers opioid efficacy with less potential for abuse and a lower risk of dependence, according to an Avenue Therapeutics representative.

Last updated on: May 22, 2018
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