Controlled Release of Naltrexone

In spite of the availability of a narcotic antagonist, naltrexone, which 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 previously 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. Preliminary clinical studies indicated that a single dose of naltrexone, given in these implantable beads, mitigated the opiate effects of morphine challenges for up to one month. 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 formula- tion 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. The treatment will be used 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 be readily accepted by the FDA when both planning clinical trials and projecting distribution are used for a larger population of patients.