Claims for Patent: RE41408

Summary for Patent: RE41408

Title:	Method of providing sustained analgesia with buprenorpine
Abstract:	A method of effectively treating pain in humans is achieved by administering buprenorphine in accordance with first order kinetics over an initial three-day dosing interval, such that a maximum plasma concentration from about 20 pg/ml to about 1052 pg/ml is attained, and thereafter maintaining the administration of buprenorphine for at least an addition two-day dosing interval in accordance with substantially zero order kinetics, such that the patients experience analgesia throughout the at least two-day additional dosing interval.
Inventor(s):	Reder; Robert F. (Greenwich, CT), Kaiko; Robert F. (Weston, CT), Goldenheim; Paul D. (Wilson, CT)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Application Number:	11/799,608
Patent Claims:	1. A method of treating human patients suffering from opioid addiction by applying a transdermal delivery system containing buprenorphine onto the skin of the patient and maintaining the transdermal delivery system in contact with the skin for a 3 day dosing interval, the transdermal delivery system containing an amount of buprenorphine sufficient to maintain an adequate relative release rate to provide a plasma concentration of from about 1000 pg/ml to about 10,000 pg/ml at the end of said 3 day dosing interval, and maintaining the transdermal delivery system in contact with the patient's skin for .[.at least 2 to about 5 .]. .Iadd.4 .Iaddend.additional days beyond said .[.3:day.]. .Iadd.3 day .Iaddend.dosing interval, such that the patient continues to receive effective treatment for opioid addiction from said transdermal buprenorphine delivery system over said dosing material. 2. The method of claim 1, wherein the plasma concentration attained at the end of said 3 day dosing interval is from about 5000 pg/ml to about 8000 pg/ml. .[.3. The method of claim 1 wherein said patch is maintained on the skin to the patient for about 7 days..]. 4. The method of claim 1 wherein said transdermal .[.patch.]. .Iadd.delivery system .Iaddend.provides a substantially first order plasma level increase of buprenorphine from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval.Iadd., and substantially zero order plasma level fluctuation of buprenorphine from about 72 hours after the initiation of the dosing interval until the end of the seven-day dosing interval.Iaddend.. .[.5. The method of claim 1 wherein said transdermal patch provides substantially zero order plasma level fluctuation of buprenorphine from about 72 hours after the initiation of the dosing interval until the end of at least the five-day dosing interval..]. .[.6. The method of claim 1 wherein said transdermal patch provides a substantially first order plasma level increase of buprenorphine from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval and provides a substantially zero order plasma level fluctuation of buprenorphine from about 72 hours after the initiation of the dosing interval until the end of at least the five-day dosing interval..]. .[.7. The method of claim 5 wherein the plasma level of buprenorphine at 72 hours does not decrease by more than 30% over the next 48 hours..]. 8. The method of claim .[.5.]. .Iadd.4 .Iaddend.wherein said .[.patch.]. .Iadd.transdermal delivery system .Iaddend.is maintained on the skin of the patient for about 7 days. .[.9. The method of claim 8 wherein the plasma level of buprenorphine at 120 hours does not decrease by more than 30% over the next 48 hours..]. 10. A method of treating pain in a human patient comprising: administering an opioid transdermally to said human patient by applying a transdermal delivery system .Iadd.comprising an opioid .Iaddend.to the skin of a patient, and maintaining said transdermal delivery system in contact with the skin of said patient for .[.at least 5.]. .Iadd.7 .Iaddend.days, said transdermal delivery system providing a substantially first order plasma level increase of said opioid from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval and providing a substantially zero order plasma level fluctuation of said opioid from about 72 hours after the initiation of the dosing interval until the end of .[.at least.]. the .[.five.]. .Iadd.seven.Iaddend.-day dosing interval. 11. The method of claim 10 wherein said opioid is buprenorphine. .Iadd.12. A method of treating human patients suffering from opioid addiction by applying a transdermal delivery system containing an active ingredient, wherein the active ingredient consists essentially of buprenorphine, onto the skin of the patient and maintaining the transdermal delivery system in contact with the skin for a 3 day dosing interval, the transdermal delivery system containing an amount of buprenorphine sufficient to maintain an adequate relative release rate to provide a plasma concentration of from about 1000 pg/ml to about 10,000 pg/ml at the end of said 3 day dosing interval, and maintaining the transdermal delivery system in contact with the patient's skin for 4 additional days beyond said 3 day dosing interval, such that the patient continues to receive effective treatment for opioid addiction from said transdermal buprenorphine delivery system over said dosing interval. .Iaddend. .Iadd.13. The method of claim 12, wherein the plasma concentration attained at the end of said 3 day dosing interval is from about 5000 pg/ml to about 8000 pg/ml. .Iaddend. .Iadd.14. The method of claim 12 wherein said transdermal delivery system provides a substantially first order plasma level increase of buprenorphine from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval, and substantially zero order plasma level fluctuation of buprenorphine from about 72 hours after the initiation of the dosing interval until the end of the seven-day dosing interval. .Iaddend. .Iadd.15. The method of claim 14 wherein said transdermal delivery system is maintained on the skin of the patient for about 7 days. .Iaddend. .Iadd.16. A method of treating human patients suffering from opioid addiction by applying a transdermal delivery system containing an active ingredient, wherein the active ingredient consists of buprenorphine, onto the skin of the patient and maintaining the transdermal delivery system in contact with the skin for a 3 day dosing interval, the transdermal delivery system containing an amount of buprenorphine sufficient to maintain an adequate relative release rate to provide a plasma concentration of from about 1000 pg/ml to about 10,000 pg/ml at the end of said 3 day dosing interval, and maintaining the transdermal delivery system in contact with the patient's skin for 4 additional days beyond said 3 day dosing interval, such that the patient continues to receive effective treatment for opioid addiction from said transdermal buprenorphine delivery system over said dosing interval. .Iaddend. .Iadd.17. The method of claim 16, wherein the plasma concentration attained at the end of said 3 day dosing interval is from about 5000 pg/ml to about 8000 pg/ml. .Iaddend. .Iadd.18. The method of claim 16 wherein said transdermal delivery system provides a substantially first order plasma level increase of buprenorphine from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval, and substantially zero order plasma level fluctuation of buprenorphine from about 72 hours after the initiation of the dosing interval until the end of the seven-day dosing interval. .Iaddend. .Iadd.19. The method of claim 18 wherein said transdermal delivery system is maintained on the skin of the patient for about 7 days. .Iaddend. .Iadd.20. A method of treating pain in a human patient comprising transdermally administering an active ingredient, wherein the active ingredient consists essentially of an opioid, to said human patient by applying a transdermal delivery system comprising an active ingredient, wherein the active ingredient consists essentially of an opioid to the skin of a patient, and maintaining said transdermal delivery system in contact with the skin of a patient for 7 days, said transdermal delivery system providing a substantially first order plasma level increase of said opioid from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval and providing a substantially zero order plasma level fluctuation of said opioid from about 72 hours after the initiation of the dosing interval until the end of the seven-day dosing interval..Iaddend. .Iadd.21. The method of claim 20 wherein said opioid is buprenorphine. .Iaddend. .Iadd.22. A method of treating pain in a human patient comprising transdermally administering an active ingredient, wherein the active ingredient consists of an opioid, to said human patient by applying a transdermal delivery system comprising an active ingredient, wherein the active ingredient consists of an opioid to the skin of a patient, and maintaining said transdermal delivery system in contact with the skin of said patient for 7 days, said transdermal delivery system providing a substantially first order plasma level increase of said opioid from the initiation of the dosing interval until about 72 hours after the initiation of the dosing interval and providing a substantially zero order plasma level fluctuation of said opioid from about 72 hours after the initiation of the dosing interval until the end of the seven-day dosing interval. .Iaddend. .Iadd.23. The method of claim 22 wherein said opioid is buprenorphine. .Iaddend.