SUSTAINED-ACTION NALMEFENE

NALMEFENE HAS BEEN SHOWN TO BE AN EFFECTIVE PHARMACOLOGICAL INTERVENTION FOR PROTECTING POSTADDICTS FROM RE-ADDICTION. WITH THIS MODALITY, IN CONTRAST TO METHADONE, THE PATIENT ISFREE OF OPIOIDS. THE OVERALL OBJECTIVE OF THIS PROGRAM DURING THE NEXT 3 YEARS IS TO DEVELOP A SUSTAINED-ACTION FORMULATION OF NALMEFENE THAT IS EFFECTIVE FOR AT LEAST A MONTH, AND TO FILE AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION WITH THE FOOD AND DRUG ADMINISTRATION. PHASE I WILL DEMONSTRATE THE FEASIBILITY OF THE PROJECT. INJECTABLE NALMEFENE MICROCAPSULES WILL BE PREPARED AND EVALUATED FOR IN VITRO DRUG RELEASE RATES, DRUG CONTENT, SURFACE MORPHOLOGY, AND SIZE DISTRIBUTION. THE DURATION OF ACTION WILL BE DETERMINED FOR PROMISING FORMULATIONS IN VIVOUSING SEVERAL ANIMAL MODELS. PHASE I STUDIES WILL PROVIDE THE METHODOLOGICAL BASIS FOR FURTHER DEVELOPMENT OF THE FORMULATION IN PHASE II. DURING PHASE II, THE PROTOTYPE DEVELOPMENT WILL BE COMPLETED, EFFICACY AND SAFETY TESTS WILL BE CONDUCTED, AND MANUFACTURING PROCEDURES WILL BE DEFINED TO SUPPORT AN IND APPLICATION IN ANTICIPATION OF HUMAN TRIALS.