Claims for Patent: 12,622,904

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Summary for Patent: 12,622,904

Title:	Buprenorphine dosing regimens
Abstract:	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.
Inventor(s):	Azmi NASSER, Celine M. Laffont, Christian A. HEIDBREDER
Assignee:	Indivior UK Ltd
Application Number:	US19/085,650
Patent Claims:	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.