Naltrexone Long Acting Formulations and Methods of Use

Abstract

The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods.

1 . A method of treating an individual in need of naltrexone comprising administering naltrexone, in the absence of co-administering alcohol, to an individual who has not undergone alcohol abstinence within three days, prior to the naltrexone administration. 
     
     
         2 . The method of  claim 1  wherein the naltrexone is administered in a long acting formulation comprising naltrexone. 
     
     
         3 . A method of increasing the days prior to occurrence of alcohol consumption in an individual in need of naltrexone comprising administering a long acting formulation comprising naltrexone, in the absence of co-administering alcohol, to an individual who has not abstained from alcohol within three days, prior to the naltrexone administration. 
     
     
         4 . The method of  claim 1  wherein the individual has not undergone alcohol abstinence within five days prior to the naltrexone administration. 
     
     
         5 . The method of  claim 2  wherein the long acting formulation of naltrexone comprises about 310 to about 480 mg of naltrexone and a biocompatible polymer wherein upon administration to the individual, the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration and wherein the biocompatible polymer is a polylactide-co-glycolide polymer. 
     
     
         6 . The method of  claim 5  wherein the long acting formulation is administered in a dose of about 380 mg of naltrexone wherein the serum AUC is about 3.3 times greater than that achieved by 50 mg/day oral administration. 
     
     
         7 . The method of  claim 5  further comprising a second administration of a long acting formulation comprising naltrexone at least about 7 days after the first administration. 
     
     
         8 . The method of  claim 5  wherein the long acting formulation is administered by injection. 
     
     
         9 . The method of  claim 2  wherein the long acting formulation of naltrexone comprises about 160 to about 240 mg of naltrexone and a biocompatible polymer wherein upon administration to the individual, the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration and wherein the biocompatible polymer is a polylactide-co-glycolide polymer. 
     
     
         10 . The method of  claim 9  wherein the long acting formulation is administered in a dose of about 190 mg of naltrexone. 
     
     
         11 . The method of  claim 9  further comprising a second administration of a long acting formulation comprising naltrexone at least about 7 days after the first administration. 
     
     
         12 . The method of  claim 9  wherein the long acting formulation is administered by injection.