Avenue Therapeutics is a New York-based, specialty pharmaceutical company founded in 2015. We are a majority controlled subsidiary company of Fortress Biotech, Inc., a biopharmaceutical company focused on acquiring, developing and commercializing novel pharmaceutical and biotechnology products.
Avenue is focused on the development of an intravenous, or IV, formulation of tramadol HCl, or IV tramadol, for the management of moderate to moderately severe postoperative pain. 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 and physicians are familiar with it. Parenteral tramadol is approved and used 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 for an intravenous dosage of tramadol in the postoperative setting.
In November 2018, Avenue entered into a two-stage acquisition agreement with InvaGen, a subsidiary of Cipla Limited, a leading global pharmaceutical company. The first stage closing occurred in February 2019 when InvaGen acquired a 33.3% stake in Avenue on a fully diluted basis. The second stage closing is subject to the satisfaction of certain closing conditions, including conditions pertaining to U.S. Food and Drug Administration approval, labeling, scheduling and the absence of any Risk Evaluation and Mitigation Strategy or similar restrictions in effect with respect to IV tramadol, as well as the expiration of any waiting period applicable to the acquisition under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.