Granted Patent B2

US 10,646,484 · App. 16/016,250 · Granted May 12, 2020

Inventors: Celine M. Laffont (Richmond, VA); Malcolm A. Young (Richmond, VA); Norma L. Fox (Richmond, VA); Barbara R. Haight (Richmond, VA); Susan M. Learned (Richmond, VA)

Assignee: INDIVIOR UK LIMITED

A61K31/485A61K9/0019A61K9/0024A61K47/22A61K47/34A61P25/36

Abstract

Claims (29)

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.

Assignments (7)

Continuity (9)