Buprenorphine dosing regimens
The disclosure provides a dosage regimen using sustained-release buprenorphine formulations to produce therapeutic levels of buprenorphine in patients for the treatment of pain or opioid use disorders.
1 . A method of treating moderate to severe opioid use disorder in an opioid-dependent human, the method comprising:
(a) administering to said opioid-dependent human, by subcutaneous injection once per month for a period of one to three months, a first composition comprising:
(i) about 14 wt % to about 22 wt % buprenorphine in the form of the free base;
(ii) about 22 wt % to about 42 wt % of a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer having an 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; and
(b) administering to said opioid-dependent human, by subcutaneous injection once per month beginning one month after the last dose of the first composition, a second composition comprising:
(i) about 14 wt % to about 22 wt % buprenorphine in the form of the free base;
(ii) about 22 wt % to about 42 wt % of a 50:50 to 80:20 poly(DL-lactide-co-glycolide) copolymer having an 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,
wherein the amount of buprenorphine in (a)(i) is greater than the amount of buprenorphine in (b)(i).
2 . The method according to claim 1 , wherein the amount of buprenorphine in (a)(i) is about 250 mg to about 350 mg.
3 . The method according to claim 2 , wherein the amount of buprenorphine in (b)(i) is about 80 mg to about 120 mg.
4 . The method according to claim 1 , wherein the amount of buprenorphine in (b)(i) is about 80 mg to about 120 mg.
5 . The method according to claim 1 , wherein the amount of buprenorphine in (b)(i) is about 300 mg.
6 . The method according to claim 1 , wherein the amount of buprenorphine in (b)(i) is 300 mg.
7 . The method according to claim 1 , wherein the amount of buprenorphine in (b)(i) is about 100 mg.
8 . The method according to claim 2 , wherein the amount of buprenorphine in (b)(i) is about 100 mg.
9 . The method according to claim 2 , wherein the amount of buprenorphine in (b)(i) is about 300 mg.