Optimized Solriamfetol Therapy for Renal Impaired Patients
Legal Citation
Summary of the Inventive Concept
A comprehensive system for personalized solriamfetol therapy in patients with impaired renal function, enhancing efficacy and reducing adverse effects through optimized dosing, monitoring, and co-therapy approaches.
Background and Problem Solved
The original patent disclosed methods for decreasing adverse effects associated with solriamfetol therapy in subjects with impaired renal function. However, the existing approach has limitations, including the need for more precise dosing calculations, better management of gastrointestinal side effects, and more effective strategies for severe renal impairment. The new inventive concept addresses these limitations by introducing a system for optimizing solriamfetol therapy, comprising dosing calculators, pharmaceutical compositions with buffering agents, and computer-implemented monitoring systems.
Detailed Description of the Inventive Concept
The new inventive concept encompasses a range of innovations, including a dosing calculator that determines an initial dose and escalation scheme based on the subject's renal function and medical history. Additionally, a method for reducing adverse effects involves administering a loading dose of solriamfetol followed by a maintenance dose, with the loading dose adjusted based on the subject's body weight. A pharmaceutical composition featuring a solriamfetol dosage form and a buffering agent reduces gastrointestinal side effects. A computer-implemented system monitors solriamfetol therapy, utilizing a database of subject-specific renal function data and a dosing algorithm to provide personalized dosing recommendations. Furthermore, a method for increasing the efficacy of solriamfetol therapy in subjects with severe renal impairment involves co-administering a renal function-enhancing agent to improve solriamfetol clearance and reduce adverse effects.
Novelty and Inventive Step
The new claims introduce a novel system for optimizing solriamfetol therapy, which is non-obvious compared to the original patent. The inventive step lies in the integration of dosing calculators, pharmaceutical compositions, and computer-implemented monitoring systems to provide a comprehensive approach for personalized solriamfetol therapy.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of artificial intelligence or machine learning algorithms to predict optimal dosing schemes, or the development of wearable devices for real-time monitoring of solriamfetol therapy. Variations of the pharmaceutical composition could involve different buffering agents or solriamfetol dosage forms.
Potential Commercial Applications and Market
The optimized solriamfetol therapy system has significant commercial potential in the pharmaceutical industry, particularly in the treatment of excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. The target market includes healthcare providers, pharmaceutical companies, and patients with impaired renal function.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical therapeutics, specifically pharmacology of central nervous system stimulants and renal function-adjusted drug dosing, with expertise in clinical pharmacokinetics and patient-specific medication management
Person of Ordinary Skill (PHOSITA) Profile
A clinical pharmacologist or pharmaceutical researcher with advanced training in drug metabolism, renal pharmacokinetics, and personalized medicine techniques, capable of understanding complex dosing strategies and medical device integration
Obviousness Rationale
A person skilled in the art would recognize that the PTD's variations represent predictable extensions of the source patent's core teachings about solriamfetol therapy in renally impaired patients. The disclosed innovations leverage standard pharmaceutical engineering techniques to address known challenges in drug dosing and patient monitoring. These variations demonstrate incremental improvements that would be obvious to a skilled practitioner seeking to optimize therapeutic outcomes.
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. |