A New Drug Application (NDA) for intravenous (IV) tramadol has been submitted by Avenue Therapeutics for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting.
The application includes data from two phase 3 clinical trials in patients following bunionectomy and abdominoplasty surgeries. Findings from the trial involving 370 patients who underwent abdominal surgery showed that compared with placebo, IV tramadol 50mg was associated with a statistically superior improvement in pain relief as measured by Sum of Pain Intensity Difference over 24 hours (P <.001). Moreover, IV tramadol demonstrated similar efficacy and safety benefits to that of IV morphine.
The NDA also includes data from an open-label safety study and an epidemiology study evaluating the abuse potential of tramadol, a centrally-acting synthetic opioid analgesic. In countries where IV tramadol is available, abuse was observed to be uncommon relative to oral tramadol, according to the study; in general, abuse of tramadol appears to be lower than with other prescription opioids.
“As a potential alternative that could reduce the use of conventional opioids, IV tramadol may fill a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space,” said Lucy Lu, MD, Avenue’s President and Chief Executive Officer. “The submission of this NDA is an important milestone for our company, and we look forward to working closely with the FDA during the review process.”
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