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US 2026/0306480 A1Published application
Rapid induction with monthly injectable buprenorphine extended-release
AssigneeIndivior UK Limited
InventorRobert L. DOBBINS
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Abstract
The disclosure provides methods of treating opioid use disorder in a human by rapid induction with monthly injectable extended release buprenorphine, and to rapid induction dosage regimens for treating opioid use disorder. The methods provide increased treatment retention compared to standard of care methods.
Claims26
1-2. (canceled)
A method of increasing the rate of retention in opioid use disorder treatment by a patient experiencing precipitated opioid withdrawal (POW), the method comprising rapid induction (RI) of buprenorphine by:
- (a) administering to the patient a transmucosal composition comprising buprenorphine as free base or a pharmaceutically acceptable salt, wherein the amount of buprenorphine is equivalent to about 2 mg to about 4 mg of buprenorphine free base,
- (b) administering a first extended-release composition to the patient by subcutaneous injection at least about 1 hour and no more than about 24 hours after administration of the transmucosal composition,
- the first extended-release composition comprising buprenorphine as free base or a pharmaceutically acceptable salt, in an amount equivalent to about 100 mg to about 300 mg of buprenorphine free base,
- (c) administering a second extended-release composition to the patient by subcutaneous injection about from about from about 7 to about 11 days after injection of the first extended-release composition,
- the second extended-release composition comprising buprenorphine as free base or a pharmaceutically acceptable salt, in an amount equivalent to about 100 mg to about 300 mg of buprenorphine free base, and
- (d) administering one or more monthly extended-release compositions to the patient by subcutaneous injection every 28 to 31 days starting 28 to 31 days after injection of the second extended-release composition,
- the monthly extended-release composition comprising buprenorphine as free base or a pharmaceutically acceptable salt, in an amount equivalent to about 100 mg to about 300 mg of buprenorphine free base,
- wherein the patient experiencing POW are fentanyl-positive, and
- wherein the rate of retention is increased through administration of the second extended-release composition relative to standard of care (SoC) and standard induction (SI) methods of buprenorphine induction.
6 more elements
Dependencies are inferred from the claim text.