Claims for Patent: 10,646,484

Summary for Patent: 10,646,484

Title:	Methods to treat opioid use disorder
Abstract:	The disclosure provides sustained-release buprenorphine formulations that produce therapeutic plasma concentration levels of buprenorphine in patients to treat opioid use disorder.
Inventor(s):	Laffont; Celine M. (Richmond, VA), Young; Malcolm A. (Richmond, VA), Fox; Norma L. (Richmond, VA), Haight; Barbara R. (Richmond, VA), Learned; Susan M. (Richmond, VA)
Assignee:	INDIVIOR UK LIMITED (Hull, GB)
Application Number:	16/016,250
Patent Claims:	1. A method of treating moderate-to-severe opioid use disorder in an injection drug patient in need thereof, the method comprising subcutaneously administering a buprenorphine composition once per month for at least six months to the injection drug patient; wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at 18 wt %; (ii) about 32 wt % of a 50:50 poly(DL-lactide-co-glycolide) copolymer having a carboxy terminal group and a weight average molecular weight of about 9,000 Daltons to about 19,000 Daltons; and (iii) about 50 wt % of N-methyl-2-pyrrolidone. 2. The method of claim 1, comprising subcutaneously administering the buprenorphine composition once per month for at least twelve months. 3. The method of claim 1, wherein the method produces opioid abstinence in the injection drug user. 4. A method of treating opioid use disorder in an injection drug patient in need thereof, the method comprising subcutaneously administering a buprenorphine composition once per month for at least six months to the injection drug patient; wherein the buprenorphine composition comprises about 300 mg buprenorphine free base, a poly(lactide-co-glycolide) copolymer, and N-methyl-2-pyrrolidone. 5. The method of claim 4, wherein the opioid use disorder is moderate-to-severe opioid use disorder. 6. The method of claim 4, wherein the opioid use disorder is moderate opioid use disorder. 7. The method of claim 4, wherein the opioid use disorder is severe opioid use disorder. 8. The method of claim 4, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 10 wt % to about 30 wt %; (ii) about 10 wt % to about 60 wt % of a 50:50 to 95:5 poly(DL-lactide-co-glycolide) copolymer having a weight average molecular weight of about 5,000 Daltons to about 40,000 Daltons; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone. 9. The method of claim 4, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 14 wt % to about 22 wt %; (ii) about 22 wt % to about 42 wt % of a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer having a weight average molecular weight of about 5,000 Daltons to about 30,000 Daltons; and (iii) about 40 wt % to about 60 wt % of N-methyl-2-pyrrolidone. 10. The method of claim 4, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at 18 wt %; (ii) about 32 wt % of a 50:50 poly(DL-lactide-co-glycolide) copolymer having a carboxy terminal group and a weight average molecular weight of about 9,000 Daltons to about 19,000 Daltons; and (iii) about 50 wt % of N-methyl-2-pyrrolidone. 11. The method of claim 4, comprising subcutaneously administering the buprenorphine composition once per month for at least twelve months. 12. The method of claim 4, wherein the method produces opioid abstinence in the injection drug user. 13. The method of claim 4, wherein the method of treating opioid use disorder is a method for reducing opioid craving. 14. The method of claim 4, wherein the method of treating opioid use disorder is a method for eliminating opioid craving. 15. The method of claim 4, wherein the method of treating opioid use disorder is a method for reducing opioid withdrawal symptoms. 16. The method of claim 4, wherein the method of treating opioid use disorder is a method for eliminating opioid withdrawal symptoms. 17. The method of claim 4, wherein the method of treating opioid use disorder is a method for reducing illicit opioid use. 18. The method of claim 4, wherein the method of treating opioid use disorder is a method for eliminating illicit opioid use. 19. The method of claim 4, wherein the injection drug patient is an intravenous injection drug patient; an intramuscular injection drug patient; or a subcutaneous injection drug patient. 20. A method of treating opioid use disorder in an injection drug patient in need thereof, the method comprising subcutaneously administering a buprenorphine composition once per month to the injection drug patient; wherein the buprenorphine composition comprises about 300 mg buprenorphine free base, a poly(lactide-co-glycolide) copolymer, and N-methyl-2-pyrrolidone. 21. The method of claim 20, wherein the opioid use disorder is moderate-to-severe opioid use disorder. 22. The method of claim 20, wherein the opioid use disorder is moderate opioid use disorder. 23. The method of claim 20, wherein the opioid use disorder is severe opioid use disorder. 24. The method of claim 20, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 10 wt % to about 30 wt %; (ii) about 10 wt % to about 60 wt % of a poly(DL-lactide-co-glycolide) copolymer; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone. 25. The method of claim 24, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 14 wt % to about 22 wt %; (ii) about 22 wt % to about 42 wt % of a poly(DL-lactide-co-glycolide) copolymer; and (iii) about 40 wt % to about 60 wt % of N-methyl-2-pyrrolidone. 26. The method of claim 25, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at 18 wt %; (ii) about 32 wt % of a poly(DL-lactide-co-glycolide) copolymer; and (iii) about 50 wt % of N-methyl-2-pyrrolidone. 27. The method of claim 20, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 10 wt % to about 30 wt %; (ii) about 10 wt % to about 60 wt % of a 50:50 to 95:5 poly(DL-lactide-co-glycolide) copolymer having a weight average molecular weight of about 5,000 Daltons to about 40,000 Daltons; and (iii) about 30 wt % to about 70 wt % of N-methyl-2-pyrrolidone. 28. The method of claim 27, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at about 14 wt % to about 22 wt %; (ii) about 22 wt % to about 42 wt % of a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer having a weight average molecular weight of about 5,000 Daltons to about 30,000 Daltons; and (iii) about 40 wt % to about 60 wt % of N-methyl-2-pyrrolidone. 29. The method of claim 28, wherein the buprenorphine composition comprises: (i) about 300 mg buprenorphine free base at 18 wt %; (ii) about 32 wt % of a 50:50 poly(DL-lactide-co-glycolide) copolymer having a carboxy terminal group and a weight average molecular weight of about 9,000 Daltons to about 19,000 Daltons; and (iii) about 50 wt % of N-methyl-2-pyrrolidone.