Fixed-Dose MS Combination Therapy Reducing Adverse Effects
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Solution Overview
Problem
Current treatments for multiple sclerosis (MS) are only partly effective in halting inflammatory tissue damage and clinical progression, often associated with significant side effects and require frequent dosing, highlighting the need for more effective, tolerable, and convenient therapeutic options.
Innovation Solution
A novel combination of dimethylfumarate with teriflunomide, fingolimod, or laquinimod in fixed-dose oral formulations, allowing for lower doses and reduced frequency of administration while maintaining or improving efficacy and minimizing adverse effects compared to individual agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If higher doses of dimethylfumarate are used to improve efficacy, then treatment effectiveness increases, but adverse effects increase
Solution Approach 1:
The patent combines dimethylfumarate with another MS treatment agent to create a fixed-dose combination therapy. This merging allows the use of lower doses of dimethylfumarate (reducing adverse effects like diarrhea and flushing) while achieving comparable or superior efficacy through the synergistic effect of the combination therapy.
2Reliability
If dosing frequency is increased to improve efficacy, then treatment effectiveness increases, but patient compliance decreases
Solution Approach 1:
The fixed-dose combination merges two MS treatments into a single oral pill that can be administered once daily. This consolidation maintains effective drug levels while significantly improving patient compliance by eliminating the need for multiple daily doses or complex dosing schedules.
3Ease of operation
If monotherapy is used to simplify treatment, then ease of administration improves, but efficacy is limited
Solution Approach 1:
The patent creates a fixed-dose combination that merges two effective MS treatments into a single administered unit. This approach maintains the simplicity of monotherapy (one pill, once daily) while delivering the enhanced efficacy of combination therapy through the synergistic interaction between dimethylfumarate and the co-administered agent.
Data Source
AI summary
The present invention relates to a method of treating MS in a human patient in need of such treatment and comprises administering to said patient a combination therapy in a single oral dosage form (e.g. a tablet or capsule) of dim ethyifurrta rate and one agent selected from teriflunomide (or its prodrug leflunomide), fingolimod and laquinimod. This combination is more effective than the single agents alone and/or has reduced side effects and better tolerability than the single agents alone and/or can be given in a reduced frequency. Moreover, the present invention is directed to a pharmaceutical composition suitable for the oral treatment of multiple sclerosis consisting of dimethylfumarate and one agent selected from teriflunomide, fingolimod and laquinimod as active ingredients and one or more pharmaceutically acceptable excipients.