Tramadol is a synthetic dual-acting opioid with a well-established efficacy and safety profile, and has been used throughout the world for more than 30 years, accumulating an abundance of available clinical data. Oral tramadol is currently approved and marketed in the United States.
Parenteral tramadol is approved and used for postoperative pain throughout much of the world, but there is no parenteral formulation currently available in the United States. We anticipate that the introduction of an intravenous formulation in the United States will address the current market need presented by the shortcomings of conventional opioids and other analgesics currently used in the postoperative setting.
As of June 2019, Avenue has completed its Phase 3 development of IV tramadol. The Phase 3 program consisted of a study in bunionectomy (an orthopedic model), a study in abdominoplasty (a soft-tissue model) and an open-label study. We plan to submit a new drug application for IV tramadol to treat moderate to moderately severe postoperative pain pursuant to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act by the end of 2019.