Buprenorphine Rapid Induction Regimen for Monthly Extended-Release Dosing

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Solution Overview

Problem

Current standard induction methods for treating opioid use disorder with buprenorphine are inadequate for high-risk populations, leading to increased treatment failure and overdose risks, particularly in patients using intravenous drugs or highly potent synthetic opioids.

Innovation Solution

A rapid induction regimen involving the administration of transmucosal buprenorphine followed by injectable extended-release buprenorphine within a short timeframe, with subsequent monthly maintenance doses, to optimize dosing and reduce treatment failure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard induction methods with stepwise dosing are used, then treatment safety is maintained, but treatment retention is reduced and treatment failure increases in high-risk populations

Engineering Contradiction:
Improvetreatment retentionVSAvoidinduction protocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary action by administering a higher initial dose of buprenorphine (16-24mg) before the patient experiences withdrawal symptoms, rather than gradually titrating up. This preliminary high-dose approach ensures therapeutic levels are achieved immediately, improving treatment retention in high-risk populations without requiring complex stepwise protocols.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the dosing parameters from standard stepwise increments (2-4mg increases over 7-14 days) to a rapid induction protocol with a single high dose (16-24mg) followed by extended-release injection within 24 hours. This parameter change simplifies the protocol while improving effectiveness for high-risk patients.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If standard induction with 7-14 days of transmucosal buprenorphine is used, then opioid withdrawal is managed gradually, but treatment failure and overdose risk increase in high-risk populations

Engineering Contradiction:
Improvetreatment success rateVSAvoidinduction duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies the skipping principle by rushing through the traditional 7-14 day induction period and administering the extended-release buprenorphine injection within 24 hours of the initial high dose. This compressed timeline skips the gradual titration phase, reducing induction duration while improving treatment success rates for high-risk patients.

Inventive Principle:
Principle #21Skipping (Rushing through)

Solution Approach 2:

The patent performs preliminary action by establishing therapeutic buprenorphine levels immediately with a 16-24mg initial dose before proceeding to the extended-release injection. This preliminary high-dose approach ensures patients are stabilized quickly, reducing induction time while maintaining treatment success.

Inventive Principle:
Principle #10Preliminary action

3Speed

If high initial doses of buprenorphine are administered, then therapeutic levels are achieved quickly, but risk of precipitated withdrawal increases

Engineering Contradiction:
Improvetime to therapeutic levelVSAvoidprecipitated withdrawal risk
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent uses an intermediary approach by administering the high initial dose (16-24mg) of immediate-release buprenorphine as a bridge before the extended-release injection. This intermediary high dose quickly achieves therapeutic levels, and the subsequent extended-release formulation maintains stable levels, allowing rapid achievement of therapeutic effect while managing withdrawal risk through the structured sequence.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the dosing parameters from gradual titration to a single high initial dose (16-24mg) followed by extended-release formulation. This parameter change achieves rapid therapeutic levels while the extended-release component prevents precipitated withdrawal by maintaining stable concentrations.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20250352522A1Rapid induction with monthly injectable buprenorphine extended-release
Publication Date: 2025.11.20 INDIVIOR UK LTD
  • US20250352522A1 patent drawing
  • US20250352522A1 patent drawing
  • US20250352522A1 patent drawing

AI summary

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.