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Controlled Release of Naltrexone

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 22423
Amount: $80,250.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 1993
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
195 Common Street
Belmont, MA 02178
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Joseph D. Gresser
 (617) 484-3184
Business Contact
Phone: () -
Research Institution

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.

* Information listed above is at the time of submission. *

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