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Avenue Therapeutics files for US FDA approval of injectable opioid pain drug

Avenue Therapeutics Inc. submitted an application seeking U.S. approval of its formulation of injectable tramadol, an opioid medicine that has been in use for decades and sold under many brand names worldwide.

Avenue's President and CEO Lucy Lu said intravenous tramadol is a potential alternative that could reduce the use of conventional opioids for pain management.

The New York-based specialty pharmaceutical company said the new drug application was backed by data from two phase 3 studies of the intravenous — administered into the veins — formulation of tramadol that showed that the drug helped reduce pain in certain patients following surgery.

Avenue noted in its Dec. 11 press release that the filing also included findings from a study that suggests that abuse with tramadol was infrequent in terms of absolute number and in comparison to other prescription opioids. Abuse of injectable tramadol, in countries where it is available, was also found to be uncommon compared to oral tramadol.

The U.S. is reeling under an opioid epidemic, which kills about 130 Americans each day, with major healthcare companies facing lawsuits from across the country over their alleged role in flaring up the crisis.