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 - 36 . (canceled) 
     
     
         37 . A method of treating opioid addiction, the method comprising subcutaneously implanting buprenorphine into a human in need thereof, thereby providing a therapeutically-effective plasma level of buprenorphine. 
     
     
         38 . The method of  claim 37 , wherein the therapeutically-effective plasma level of buprenorphine is from about 0.1 ng/ml to about 70 ng/ml. 
     
     
         39 . The method of  claim 37 , wherein the therapeutically-effective plasma level of buprenorphine is from about 0.1 ng/ml to about 1 ng/ml. 
     
     
         40 . The method of  claim 37 , wherein the therapeutically-effective plasma level of buprenorphine is about 0.5 ng/ml. 
     
     
         41 . The method of  claim 37 , wherein the therapeutically-effective plasma level of buprenorphine is sustained for at least 3 months. 
     
     
         42 . The method of  claim 37 , wherein the buprenorphine is a pharmaceutically-acceptable salt. 
     
     
         43 . The method of  claim 37 , wherein the buprenorphine is buprenorphine hydrochloride. 
     
     
         44 . The method of  claim 37 , wherein the buprenorphine is implanted with a carrier. 
     
     
         45 . The method of  claim 44 , wherein the carrier is a polymer matrix. 
     
     
         46 . The method of  claim 45 , wherein the polymer comprises ethylene vinyl acetate. 
     
     
         47 . A method of treating opioid addiction and pain, the method comprising subcutaneously implanting into a subject in need thereof a therapeutically-effective amount of buprenorphine. 
     
     
         48 . The method of  claim 47 , wherein the therapeutically-effective amount is from about 0.1 mg per day to about 5 mg per day. 
     
     
         49 . The method of  claim 47 , wherein the therapeutically-effective amount is from about 0.2 mg per day to about 1 mg per day. 
     
     
         50 . The method of  claim 47 , wherein the therapeutically-effective amount is about 0.3 mg per day. 
     
     
         51 . The method of  claim 47 , wherein the subject receives a therapeutically-effective plasma level of buprenorphine. 
     
     
         52 . The method of  claim 51 , wherein the therapeutically-effective plasma level is from about 0.1 ng/ml to about 70 ng/ml. 
     
     
         53 . The method of  claim 51 , wherein the therapeutically-effective plasma level is from about 0.1 ng/ml to about 1 ng/ml. 
     
     
         54 . The method of  claim 51 , wherein the therapeutically-effective plasma level is from about 1 ng/ml to about 10 ng/ml. 
     
     
         55 . The method of  claim 51 , wherein the therapeutically-effective plasma level is about 0.5 ng/ml. 
     
     
         56 . The method of  claim 51 , wherein the therapeutically-effective plasma level is sustained for at least 3 months. 
     
     
         57 . The method of  claim 47 , wherein the buprenorphine is a pharmaceutically-acceptable salt. 
     
     
         58 . The method of  claim 47 , wherein the buprenorphine is buprenorphine hydrochloride. 
     
     
         59 . The method of  claim 47 , wherein the buprenorphine is implanted with a carrier. 
     
     
         60 . The method of  claim 59 , wherein the carrier is a polymer matrix. 
     
     
         61 . The method of  claim 60 , wherein the polymer matrix comprises ethylene vinyl acetate. 
     
     
         62 . The method of  claim 47 , wherein the subject is human.