ANN ARBOR, MI--(Marketwire - October 26, 2012) - TSRL, Inc. is a privately-owned specialty pharmaceutical company focused on the discovery and development of orally available antiviral and anticancer therapeutics based on its proprietary prodrug technology.
The company announced today that it reached agreement with the FDA on its preclinical and clinical development strategy at a pre-IND meeting for TSR-026, an oral prodrug of zanamivir. The product will be developed to follow a 505(b)2 submission pathway. The marketing application will be supported by published literature and the Agency's prior finding of safety and effectiveness for zanamivir (Relenza®) for treatment of uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 2 days.
This is a key milestone for TSR-026, which has been developed to date through SBIR funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).