Claims for Patent: 9,901,539

Summary for Patent: 9,901,539

Title:	Transmucosal drug delivery devices for use in chronic pain relief
Abstract:	Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.
Inventor(s):	Finn; Andrew (Raleigh, NC), Vasisht; Niraj (Cary, NC)
Assignee:	BioDelivery Sciences International, Inc. (Raleigh, NC)
Application Number:	13/724,959
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,901,539
Patent Claims:	1. A method of treating chronic pain, the method comprising: administering to a subject in need thereof a mucoadhesive bioerodable drug delivery device, wherein the device is administered once or twice daily, wherein the device comprises: a bioerodable mucoadhesive layer comprising about 100 g to about 0.9 mg buprenorphine and buffered to a pH of between about 4.0 and about 6.0; and a backing layer buffered to a pH of between about 4.0 and about 4.8 and that does not include an opioid antagonist; wherein the device provides a steady-state C.sub.max of plasma buprenorphine concentration in a range between about 0.156 and about 0.364 ng/mL; wherein the subject is an opioid-experienced subject; and wherein the subject treated experiences mild or moderate common opioid adverse effects, or no common opioid adverse effects. 2. The method according to claim 1, wherein the device is administered once daily. 3. The method according to claim 1, wherein the chronic pain is chronic low back pain. 4. The method according to claim 1, wherein the chronic pain is moderate to severe chronic low back pain. 5. The method according to claim 1, wherein the subject is treated without significant constipation. 6. The method according to claim 1, wherein the subject is treated without significant nausea. 7. The method according to claim 1, wherein the total daily dose of buprenorphine administered to the subject is selected from the group consisting of 200 g, 220 g, 240 g, 280 g, 300 g, 320 g, 350 g, 360g, 400 g, 450 g, 480 g, 500 g, 550 g, 600 g, 620 g, 650 g, 700 g, 720 g, 750 g, 800 g, 860 g, 900 g, 960 g, 1000 g, 1100 g, 1200 g, 1250 g, 1300 g, 1400 g, 1500 g, 1600 g, and 1800 g of buprenorphine. 8. The method according to claim 1, wherein the mucoadhesive bioerodable drug delivery device further comprises a barrier layer comprising: a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient upon application to a mucosal surface for the rapid and efficient delivery of buprenorphine, wherein the unidirectional gradient delivers buprenorphine across the buffered polymeric diffusion environment upon application to the mucosal surface. 9. A method of treating a subject with moderate to severe chronic low back pain, comprising: administering to the subject twice daily a mucoadhesive bioerodable drug delivery device to an oral mucosal surface of the subject, the device comprising: a bioerodable mucoadhesive layer comprising an effective amount of buprenorphine disposed in a buffered polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6; and a backing layer buffered to a pH between about 4.0 and about 4.8 and that does not include an opioid antagonist; wherein the total daily dose of buprenorphine administered to the subject is effective for treating moderate to severe chronic low back pain; wherein the subject is an opioid-experienced subject; and wherein the subject treated experiences mild or moderate common opioid adverse effects, or no common opioid adverse effects. 10. The method according to claim 1, wherein said chronic pain is neuropathic pain. 11. The method according to claim 1, wherein said chronic pain is osteoarthritic pain. 12. The method according to claim 1, wherein the device comprises a dose of buprenorphine selected from the group consisting of 100 g, 110 g, 120 g, 140 g, 150 g, 160 g, 175 g, and 180g. 13. The method according to claim 1, wherein the total daily dose of buprenorphine administered to the subject ranges from 200 g to about 1800 .mu.g. 14. The method according to claim 1, wherein steady-state T.sub.max of buprenorphine is in a range between about 2.00 and about 2.90 h. 15. The method according to claim 1, wherein C.sub.min of buprenorphine is in a range between about 0.0157 and about 0.0862 ng/mL. 16. The method according to claim 1, wherein steady-state AUC.sub.last of buprenorphine is in a range between about 0.4085 and about 5.033 h*ng/mL. 17. The method according to claim 1, wherein between about 2.4-6.9% of subjects experience drug related mild or moderate headaches as a treatment emergent adverse event (TEAE). 18. The method according to claim 1, wherein between about 3-6.9% of subjects experience drug related mild or moderate dizziness as a TEAE. 19. The method according to claim 1, wherein between about 2.6-27.9% of subjects experience drug related mild or moderate nausea as a TEAE. 20. The method according to claim 1, wherein between about 1.5-8.5% of subjects experience drug related mild or moderate constipation as a TEAE. 21. The method according to claim 1, wherein between about 0.9-3% of subjects experience drug related mild or moderate vomiting as a TEAE. 22. The method according to claim 1, wherein between about 7.7-33.9% of subjects experience drug related mild or moderate TEAEs.