Avenue Therapeutics, Inc. is a clinical‐stage pharmaceutical company focused on developing and commercializing intravenous therapeutics for acute care settings in hospitals and other inpatient environments. Founded in 2015 and headquartered in Radnor, Pennsylvania, the company’s mission is to address significant unmet medical needs for pain management and other acute indications. Avenue Therapeutics operates primarily in the United States but leverages global partnerships for clinical development and manufacturing.
The company’s lead product candidate is intravenous tramadol, which is being developed for the management of moderate to severe acute pain in adults. Tramadol is a well‐characterized opioid analgesic with a dual mechanism of action, and the intravenous formulation aims to provide rapid and controlled pain relief in postoperative and trauma patients. Avenue Therapeutics completed a pivotal Phase III clinical trial in the United States and has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration. The company is also investigating additional acute care applications to broaden its product portfolio.
To support its development programs, Avenue Therapeutics has established strategic partnerships for manufacturing and supply chain management. Key collaborations include an agreement with a contract development and manufacturing organization (CDMO) in Asia for commercial‐scale production of its intravenous formulations. The company’s research and clinical teams engage with leading academic medical centers across multiple regions to conduct clinical trials, ensuring robust data generation and regulatory compliance. Avenue Therapeutics also maintains an active dialogue with healthcare professionals to inform its product development and market access strategies.
Leadership at Avenue Therapeutics is comprised of industry veterans with extensive experience in biopharmaceutical development, regulatory affairs, and commercial operations. The executive team is led by Carl O. Schwartz, Chief Executive Officer, who has previously held senior roles in both specialty pharmaceutical companies and global life sciences firms. The board and management collectively guide the company through late‐stage development milestones and toward potential commercialization, with a focus on delivering intravenous therapies that improve patient outcomes in acute care settings.
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