Auris Medical Gets FDA's Fast Track Designation for its Keyzilen in Acute Peripheral Tinnitus

Auris Medical Holding AG

disclosed that the Food and Drug Administration (FDA) has granted a fast track status for its KeyzilenTM (AM-101) in acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults. Auris Medical said that the Fast Track program was established by the regulator to make possible the development, as well as, expedite the review of new drugs, which were planned to treat serious conditions and fill an unmet medical need. The company added that the object is to get important new drugs to the patient earlier. The company indicated that a drug, which gets Fast Track status, is granted more frequent access to the regulator to review the drug's development plan and might become eligible for priority review if relevant criteria are met. Its founder, Chairman and CEO, Thomas Meyer, commented, "We are very pleased to have received Fast Track designation for Keyzilen from the FDA. Acute peripheral tinnitus is a serious condition that negatively impacts the quality of life for those suffering from it, yet there is no clinically proven pharmacological treatment or other effective therapy available." Auris' Head of Regulatory and Quality Affairs, Andrew Braun, said, "We very much appreciate the FDA's support in the development of Keyzilen and look forward to working with the Agency to advance this potential first-in-class treatment." The stock traded 4.37 percent higher on Monday.