The objective of this two-phase program is to demonstrate the technical feasibility of manufacturing, clinically testing and commercializing an intraoral fluoride-releasing system (IFRS) for high-caries-risk patients which is superior to the currently marketed oral care products. Demonstration of product uniformity, fluoride release at a constant rate, reproducibility of the manufacturing process and filing an Investigational New Drug Application (INDA) with the U.S. Food and Drug Administration (FDA) constitutes the major milestones of the Phase I program. Meeting these milestones is a prerequisite for achieving the long-term Phase II objectives. As part of the Small Business Innovative Research (SBIR) Grant, Phase II program, the optimized IFRS will be tested in healthy adults to establish product safety and fluoride release from the IFRS into the oral cavity. Once safety and fluoride release rates are established, human efficiency trials with selected high-caries-risk xerostomia patients and persons having difficulties carrying out oral hygiene procedures will be initiated. Upon successful completion of the clinical studies, a New Drug Application (NDA) will be filed with the FDA. Concurrently, the large-scale production and commercialization of the IFRS will be initiated.
