Implantable polymeric device for sustained release of buprenorphine

Abstract

The present invention provides compositions, methods, and kits for treatment of opiate addiction and pain. The invention provides a biocompatible nonerodible polymeric device which releases buprenorphine continuously with generally linear release kinetics for extended periods of time. Buprenorphine is released through pores that open to the surface of the polymeric matrix in which it is encapsulated. The device may be administered subcutaneously to an individual in need of continuous treatment with buprenorphine.

1 - 55 . (canceled) 
     
     
         56 . A method for treating opioid addiction in a human in need thereof, the method comprising subcutaneously implanting into the human at least one implantable device comprising buprenorphine and a polymer matrix, wherein the buprenorphine is released from the implantable device at a rate that results in a therapeutically-effective plasma level in the human of about 0.1 ng/ml to about 70 ng/ml. 
     
     
         57 . The method of  claim 56 , wherein the plasma level of buprenorphine ranges from 0.1 ng/ml to 0.5 ng/ml. 
     
     
         58 . The method of  claim 56 , wherein the plasma level of buprenorphine ranges from 4 ng/ml to 70 ng/ml. 
     
     
         59 . The method of  claim 56 , wherein the rate of buprenorphine release is associated with the porosity of the polymer matrix. 
     
     
         60 . The method of  claim 56 , wherein the polymer is non-erodable. 
     
     
         61 . The method of  claim 56 , wherein the polymer comprises ethylene vinyl acetate. 
     
     
         62 . The method of  claim 56 , wherein the device releases a therapeutically effective level of buprenorphine for at least 3 months. 
     
     
         63 . The method of  claim 56 , wherein the buprenorphine is a pharmaceutically-acceptable salt. 
     
     
         64 . The method of  claim 56 , wherein the buprenorphine is buprenorphine hydrochloride. 
     
     
         65 . An implantable device comprising:
 a) a polymer matrix; and   b) buprenorphine,   
       wherein upon implantation of the device in a human, the device releases buprenorphine at a rate that results in a therapeutically effective plasma level in the human of about 0.1 ng/ml to about 70 ng/ml. 
     
     
         66 . The device of  claim 65 , wherein the rate of release is associated with a porosity of the polymer matrix. 
     
     
         67 . The device of  claim 65 , wherein the device further comprises a hydrophobic coating. 
     
     
         68 . The device of  claim 65 , wherein the polymer comprises ethylene vinyl acetate. 
     
     
         69 . The device of  claim 65 , wherein the polymer is non-erodible. 
     
     
         70 . The device of  claim 65 , wherein the buprenorphine is a pharmaceutically-acceptable salt. 
     
     
         71 . The device of  claim 65 , wherein the buprenorphine is buprenorphine hydrochloride. 
     
     
         72 . The device of  claim 65 , wherein the plasma level of buprenorphine ranges from 0.1 ng/ml to 0.5 ng/ml. 
     
     
         73 . The device of  claim 65 , wherein the plasma level of buprenorphine ranges from 4 ng/ml to 70 ng/ml.