Optimized Solriamfetol Therapy for Renal Impaired Patients

Publication ID: 24-11857528_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Optimized Solriamfetol Therapy for Renal Impaired Patients,” Published Technical Disclosure No. 24-11857528_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857528_0001_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,528.

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.

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

Source Patent Element
Method of treating excessive daytime sleepiness in subjects with renal impairment using specific dosing protocols
PTD Variation
Dosing calculator system that determines initial dose and escalation scheme based on renal function and medical history
Obviousness Reasoning
Implementing computational tools to standardize and personalize drug dosing is a known technique in clinical pharmacology, representing a predictable application of digital technology to existing medical protocols
Source Patent Element
Specific oral daily dosing for patients with impaired renal function
PTD Variation
Loading dose methodology adjusted by patient body weight with subsequent maintenance dosing
Obviousness Reasoning
Weight-based dosing is a standard pharmaceutical approach for managing drug pharmacokinetics, particularly in patients with variable metabolic profiles
Source Patent Element
Treatment of excessive daytime sleepiness in patients with renal impairment
PTD Variation
Pharmaceutical composition incorporating buffering agents to reduce gastrointestinal side effects
Obviousness Reasoning
Modifying drug formulations to mitigate side effects is a routine strategy in pharmaceutical development, representing an obvious solution to known adverse effect challenges
Source Patent Element
Solriamfetol therapy for patients with varying levels of renal impairment
PTD Variation
Computer-implemented monitoring system with personalized dosing recommendation algorithm
Obviousness Reasoning
Integration of digital monitoring systems with pharmaceutical protocols is a predictable technological advancement in personalized medicine
Source Patent Element
Treatment method for subjects with renal impairment
PTD Variation
Co-administration of renal function-enhancing agents to improve drug clearance
Obviousness Reasoning
Combinatorial therapeutic approaches to optimize drug metabolism are well-established in clinical pharmacology, representing a logical extension of existing treatment strategies
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857528, a person having ordinary skill in the art would find the variations disclosed in this published technical disclosure to represent obvious modifications to the existing solriamfetol therapy methodology. The incremental innovations demonstrate predictable applications of known pharmaceutical engineering techniques to address clinical challenges in renal-impaired patient treatment, thereby rendering potential derivative claims obvious and non-patentable under standard obviousness analysis.

Original Patent Information

Patent NumberUS 11,857,528
TitleMethods of providing solriamfetol therapy to subjects with impaired renal function
Assignee(s)AXSOME MALTA LTD.