In spite of the availability of a narcotic antagonist, naltrexone, would could be successful in the attenuation of alcohol drinking behavior, the societal problems of alcohol addiction remain. A major obstacle in achieving success with drug treatment regimes is in patient compliance. In closely related work for treatment of narcotic addiction our team earlier developed for NIH/NIDA a biodegradable controlled release delivery system in the form of implantable beads made from a polylactic-co-glycolic acid (PLGA) polymer. In preliminary clinical studies, a single dose of naltrexone, given in these implantable beads, mitigated the opiate effects of morphine challenges for up to one month after administration. These beads were of immediate utility in evaluating the concept of using an implant in treatment regimes for drug abuse. Our firm has developed a proprietary non-solvent technology for the formulation of PLGA/drug controlled release systems which maintains the advantageous characteristics of earlier solvent-based drug delivery systems. In this program, we are further developing the naltrexone/PLGA controlled release system with the goal of a single-dose naltrexone treatment for use in a one-month treatment regimen specific for the attenuation of alcohol drinking behavior. Because of the non-solvent formulation basis to our technology, the resultant system will find more ready acceptance by the FDA when both planning clinical trials and projecting distribution and use for a larger population of patients.
