DEVELOPMENT OF A LONG-ACTING DISULFIRAM

THE LONG-TERM OBJECTIVE OF THE PROPOSED PROGRAM IS TO DEVELOP A CONTROLLED-RELEASE DISULFIRAM IMPLANT FOR USE IN THE TREATMENT OF ALCOHOLISM. SPECIFIC PHASE I GOALS ARE 1. TO DESIGN CANDIDATE SYSTEMS, BASED ON TARGET PERFORMANCE TO BE DETERMINED FROM A REVIEW OF PRIOR RESEARCH, 2. TO PREPARE A SERIES OF CANDIDATE SYSTEMS, AND 3. TO DETERMINE THE IN VITRO DRUG RELEASE FROM THESE CANDIDATES. THE PROPOSED SYSTEM IS BASED ON A MEMBRANE-CONTROLLED BIOERODIBLE IMPLANT THAT WOULD DELIVER DISULFIRAM AT A CONSTANT RATE FOR SEVERAL WEEKS, RESULTING IN IMPROVED EFFICACY, GREATER PATIENT COMPLIANCE, AND FEWER SIDE EFFECTS THAN CURRENT THERAPY. SUCCESS IN THE PHASE I PROGRAM WOULD LEAD TO PROTOTYPE DEVELOPMENT, ANIMAL EFFICACY STUDIES, TOXICITY TESTING, AND FILING OF AN IND IN PHASE II FOR SUBSEQUENT HUMAN EFFICACY AND SAFETY STUDIES.