The overall objective of this program is to commercially develop a novel Intraoral Salivary Flow Stimulant (ISFS) releasing system for radiation- induced xerostomia patients which is superior to the currently marketed orally administered products in that is does not rely on patient compliance for effectiveness in alleviating xerostomia. The broad objectives of this Phase I proposal are to demonstrate the technical feasibility of preparing 3-5,000 ISFS releasing devices per batch with 0 mg/day, 0.4 mg/day and 2.0 mg/day of SFS-releasing rates that provide continuous relief of xerostomia for twenty days to three months, are easily replaceable by a trained health professional and do not depend on patient compliance for effectiveness. Specific objectives are to characterize the ISFS-releasing devices for drug content, uniformity of dosage, kinetics of drug release and determine the systemic toxicity of the drug-containing devices in appropriate animal models. If the initial results are promising, ISFS-product development will continue, chronic toxicity in appropriate animal models will be determined, and the generated information will be assembled into an Investigational New Drug (IND) application and filed with the Food and Drug Administration (FDA) for the initiation of safety and efficacy clinical studies as part of the Phase II SBI program.
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