Personalized Migraine Treatment with Ubrogepant

Publication ID: 24-11857542_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Personalized Migraine Treatment with Ubrogepant,” Published Technical Disclosure No. 24-11857542_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857542_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. 11,857,542.

Summary of the Inventive Concept

The present inventive concept discloses novel methods and compositions for the acute treatment of migraine, addressing the limitations of existing treatments by incorporating genetic testing, personalized dosing, and bioavailability enhancers to improve efficacy and safety.

Background and Problem Solved

The original patent disclosed methods for treating migraine using ubrogepant, but it did not address the variability in patient response due to genetic differences. The present inventive concept solves this problem by incorporating genetic testing to determine a patient's CGRP receptor sensitivity, allowing for personalized dosing and reducing the risk of adverse effects.

Detailed Description of the Inventive Concept

The inventive concept comprises a genetic testing module to determine a patient's genetic predisposition to CGRP receptor sensitivity. Based on the test results, a dosing module calculates a personalized dose of ubrogepant. The pharmaceutical composition may include a bioavailability enhancer, such as cyclodextrins, lipids, or surfactants, to improve the absorption of ubrogepant. Additionally, the inventive concept includes methods for rapid migraine pain relief using fast-dissolving excipients and reducing the risk of CGRP receptor antagonist-associated adverse effects by combining ubrogepant with a gastrointestinal protective agent.

Novelty and Inventive Step

The present inventive concept is novel and non-obvious in its incorporation of genetic testing and personalized dosing, which addresses the variability in patient response and reduces the risk of adverse effects. The use of bioavailability enhancers and fast-dissolving excipients further improves the efficacy and safety of the treatment.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include using different genetic testing methods, such as whole-genome sequencing or gene expression analysis. The pharmaceutical composition may also include other active ingredients, such as anti-inflammatory agents, to enhance the treatment's efficacy. Additionally, the inventive concept may be adapted for use in other conditions, such as cluster headaches or fibromyalgia, where CGRP receptor antagonists have shown promise.

Potential Commercial Applications and Market

The present inventive concept has significant commercial potential in the treatment of migraine, a market estimated to reach $8.7 billion by 2025. The personalized approach and improved efficacy and safety profile of the inventive concept are likely to appeal to patients and healthcare providers, offering a competitive advantage over existing treatments.

Field of Art

Pharmaceutical medicine, specifically neurological treatment and drug delivery for migraine management, requiring advanced knowledge of pharmacology, receptor pharmacodynamics, and personalized medicine techniques

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical researcher or clinical pharmacologist with expertise in neuropharmacology, genetic testing, drug formulation, and CGRP receptor antagonist technologies, holding advanced degrees and practical experience in drug development

Obviousness Rationale

A PHOSITA would recognize that personalizing ubrogepant dosing through genetic testing and enhancing bioavailability are logical extensions of existing migraine treatment strategies. The proposed variations represent predictable improvements in drug delivery and patient-specific treatment optimization. These modifications align with established pharmaceutical research approaches of tailoring medication based on individual genetic profiles and improving drug absorption mechanisms.

Obvious Combinations & Variations

Source Patent Element
Acute migraine treatment method using ubrogepant
PTD Variation
Genetic testing to determine personalized ubrogepant dosing
Obviousness Reasoning
Known pharmacogenetic techniques enable dose optimization based on individual receptor sensitivity, representing a predictable application of personalized medicine principles
Source Patent Element
Fixed 50 mg ubrogepant dosing
PTD Variation
Adjustable dosing based on genetic predisposition
Obviousness Reasoning
Variability in patient drug metabolism is a well-established concept, making genetic-based dose adjustment an obvious design choice for improving treatment efficacy
Source Patent Element
Oral administration of ubrogepant
PTD Variation
Adding bioavailability enhancers like cyclodextrins
Obviousness Reasoning
Pharmaceutical formulation techniques for improving drug absorption are standard practice, with cyclodextrins being a known and predictable method for enhancing drug delivery
Source Patent Element
Migraine treatment using CGRP receptor antagonist
PTD Variation
Combining ubrogepant with gastrointestinal protective agent
Obviousness Reasoning
Mitigating potential side effects through co-administration is a standard pharmaceutical approach, representing a logical extension of existing treatment strategies
Source Patent Element
Standard oral tablet formulation
PTD Variation
Fast-dissolving excipient formulation
Obviousness Reasoning
Rapid drug delivery technologies are well-known in pharmaceutical development, making fast-dissolving formulations an obvious improvement for patient convenience
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857542 and the disclosed variations, a person having ordinary skill in the art would find the claimed innovations obvious. The proposed methods of personalized dosing, bioavailability enhancement, and formulation modifications represent predictable extensions of existing migraine treatment technologies, lacking the requisite non-obviousness for patent protection under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,542
TitleTreatment of migraine
Assignee(s)Allergan Pharmaceuticals International Limited