Personalized Solriamfetol Therapy for Impaired Renal Function
Legal Citation
Summary of the Inventive Concept
An optimized system for solriamfetol therapy in subjects with impaired renal function, providing personalized dosing, treatment outcome monitoring, and adaptive dose adjustment to minimize adverse effects.
Background and Problem Solved
The original patent disclosed methods for decreasing adverse effects associated with solriamfetol therapy in subjects with impaired renal function. However, it did not provide a comprehensive system for personalized dosing, treatment outcome monitoring, and adaptive dose adjustment. The new inventive concept addresses this limitation by introducing a system that integrates renal function assessment, dosing optimization, and treatment outcome monitoring to ensure safe and effective solriamfetol therapy.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for personalized solriamfetol therapy, including a renal function assessment module, a dosing optimization module, and a treatment outcome monitoring module. The dosing optimization module adjusts the solriamfetol dose based on the subject's renal function and treatment outcome. The system can be implemented as a computer-implemented system, a pharmaceutical composition, or a method for reducing adverse effects associated with solriamfetol therapy. The system provides a recommended solriamfetol dose based on the subject's renal function and treatment outcome prediction, ensuring a reduced risk of adverse effects in subjects with moderate renal impairment.
Novelty and Inventive Step
The new inventive concept introduces a novel system for personalized solriamfetol therapy, which is not obvious from the original patent. The integration of renal function assessment, dosing optimization, and treatment outcome monitoring provides a non-obvious solution to the problem of adverse effects associated with solriamfetol therapy in subjects with impaired renal function.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept include the use of machine learning algorithms to predict treatment outcomes, the integration of wearable devices for real-time renal function monitoring, and the development of mobile applications for patient engagement and treatment adherence.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the treatment of excessive daytime sleepiness in subjects with impaired renal function. The system can be marketed as a comprehensive solution for personalized solriamfetol therapy, providing a competitive advantage in the market.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical therapeutics, specifically pharmacology of central nervous system stimulants and renal function-adjusted drug dosing, requiring advanced knowledge of pharmacokinetics, clinical pharmacology, and medical device/software design
Person of Ordinary Skill (PHOSITA) Profile
A clinical pharmacologist or pharmaceutical researcher with expertise in drug dosing strategies, renal function assessment, and computational healthcare technologies, holding advanced degrees in pharmacy, medicine, or biomedical engineering
Obviousness Rationale
A PHOSITA would recognize that the personalized dosing system represents a predictable extension of the source patent's core teachings about solriamfetol therapy in renally impaired patients. The computational approach to dose optimization is a natural progression of the patent's existing dosing methodology, utilizing standard medical informatics techniques to implement a more dynamic and responsive treatment protocol. The integration of monitoring and adaptive dosing follows directly from the source patent's fundamental goal of minimizing adverse effects in patients with compromised renal function.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,528 |
|---|---|
| Title | Methods of providing solriamfetol therapy to subjects with impaired renal function |
| Assignee(s) | AXSOME MALTA LTD. |