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Avadel Pharmaceuticals and nference Announce Publication of Real-World Data in Sleep Advances

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Avadel Pharmaceuticals (AVDL) and nference published real-world data in Sleep Advances analyzing demographic characteristics and comorbidities in narcolepsy patients. The study, based on electronic health data from over 2,000 narcolepsy patients and 2,000 matched controls through Mayo Clinic Platform, revealed that people with narcolepsy were more likely to have psychiatric, sleep, and pain disorders. Unlike previous claims-based studies, cardiovascular disease was not among the top 20 comorbidities. This marks the first real-world study in narcolepsy using aggregate electronic health record data.

Avadel Pharmaceuticals (AVDL) e nference hanno pubblicato dati reali in Sleep Advances analizzando le caratteristiche demografiche e le comorbidità nei pazienti con narcolessia. Lo studio, basato su dati sanitari elettronici di oltre 2.000 pazienti con narcolessia e 2.000 controlli abbinati tramite la Mayo Clinic Platform, ha rivelato che le persone con narcolessia avevano maggiori probabilità di avere disturbi psichiatrici, del sonno e dolori. A differenza degli studi precedenti basati su reclami, le malattie cardiovascolari non erano tra le prime 20 comorbidità. Questo segna il primo studio reale sulla narcolessia che utilizza dati aggregati di cartelle cliniche elettroniche.

Avadel Pharmaceuticals (AVDL) y nference publicaron datos del mundo real en Sleep Advances analizando las características demográficas y las comorbilidades en pacientes con narcolepsia. El estudio, basado en datos de salud electrónicos de más de 2,000 pacientes con narcolepsia y 2,000 controles emparejados a través de la Mayo Clinic Platform, reveló que las personas con narcolepsia tenían más probabilidades de tener trastornos psiquiátricos, del sueño y del dolor. A diferencia de estudios anteriores basados en reclamaciones, las enfermedades cardiovasculares no estaban entre las 20 principales comorbilidades. Este es el primer estudio del mundo real sobre la narcolepsia que utiliza datos agregados de registros de salud electrónicos.

Avadel Pharmaceuticals (AVDL)와 nference는 Sleep Advances에 나르콜렙시 환자의 인구 통계적 특성과 동반 질병을 분석한 실제 데이터를 발표했습니다. Mayo Clinic Platform을 통해 2,000명의 나르콜렙시 환자와 2,000명의 일치하는 대조군의 전자 건강 데이터를 기반으로 한 이 연구는 나르콜렙시 환자들이 정신과, 수면 및 통증 장애를 겪을 가능성이 더 높다는 것을 밝혀냈습니다. 이전의 청구 기반 연구와 달리, 심혈관 질환은 20대 동반 질병 목록에 포함되지 않았습니다. 이는 집계된 전자 건강 기록 데이터를 사용한 나르콜렙시에 관한 첫 번째 실제 연구입니다.

Avadel Pharmaceuticals (AVDL) et nference ont publié des données du monde réel dans Sleep Advances analysant les caractéristiques démographiques et les comorbidités chez les patients atteints de narcolepsie. L'étude, basée sur des données de santé électroniques de plus de 2 000 patients narcoleptiques et 2 000 témoins appariés via la Mayo Clinic Platform, a révélé que les personnes atteintes de narcolepsie étaient plus susceptibles d'avoir des troubles psychiatriques, du sommeil et des douleurs. Contrairement aux études précédentes basées sur des demandes, les maladies cardiovasculaires ne figuraient pas parmi les 20 principales comorbidités. Cela marque la première étude du monde réel sur la narcolepsie utilisant des données agrégées de dossiers de santé électroniques.

Avadel Pharmaceuticals (AVDL) und nference haben in Sleep Advances reale Daten veröffentlicht, die demografische Merkmale und Komorbiditäten bei Patienten mit Narkolepsie analysieren. Die Studie, die auf elektronischen Gesundheitsdaten von über 2.000 Narkolepsie-Patienten und 2.000 passenden Kontrollen von der Mayo Clinic Platform beruht, ergab, dass Menschen mit Narkolepsie häufiger unter psychiatrischen, Schlaf- und Schmerzstörungen litten. Im Gegensatz zu früheren, auf Ansprüchen basierenden Studien war Herzkrankheit nicht unter den 20 häufigsten Komorbiditäten. Dies ist die erste Studie aus der realen Welt zur Narkolepsie, die aggregierte elektronische Gesundheitsdaten nutzt.

Positive
  • First-of-its-kind real-world study using electronic health record data in narcolepsy
  • Large-scale study with over 2,000 narcolepsy patients providing comprehensive clinical insights
  • Collaboration with prestigious Mayo Clinic Platform enhancing research credibility
Negative
  • None.

Insights

This publication of real-world data from Mayo Clinic, while scientifically interesting, has direct impact on Avadel Pharmaceuticals' immediate business prospects or stock value. The study primarily confirms known associations between narcolepsy and various comorbidities, with the notable finding that cardiovascular disease wasn't among the top comorbidities, contrary to previous claims-based studies.

The research collaboration with Mayo Clinic Platform and nference demonstrates Avadel's commitment to understanding their target patient population, but doesn't introduce new revenue streams, impact current drug sales, or materially affect the company's market position. While the findings may help inform clinical practice and patient care, they don't represent a significant catalyst for stock movement or company valuation.

Data demonstrated people with narcolepsy were significantly more likely to have sleep, mood and pain disorders

DUBLIN, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, and nference, a health tech company dedicated to making biomedical data computable, today announced the publication of real-world data that identified the demographic characteristics and the top 20 most prevalent comorbidities of people living with narcolepsy.

The paper, titled “Demographic Characteristics and Comorbidities of Patients With Narcolepsy: A Propensity-Matched Cohort Study,” was published online in Sleep Advances. These real-world findings were previously presented at the American Neurological Association (ANA) Annual Meeting in October 2022.

Results describing demographic characteristics and the top 20 comorbidities were based on a review of deidentified electronic health data from more than 2,000 people with narcolepsy and 2,000 matched controls. The retrospective analysis was conducted through Mayo Clinic Platform, which leverages nference’s AI software to provide access to curated, deidentified electronic health data in a secure, privacy-protected environment. These types of data provide a more comprehensive view of patient information than claims data alone.

“This is the first real-world study in narcolepsy to use aggregate electronic health record data,” said Melissa Lipford, M.D., a neurologist at the Center for Sleep Medicine at Mayo Clinic and lead author of the published paper. “We found that people with narcolepsy were more likely to have psychiatric, sleep and pain disorders. Understanding which comorbid conditions are most common should help clinicians better understand the challenges faced by patients with narcolepsy and help them optimize the management of their symptoms with the most appropriate treatment.” 

“We were proud to collaborate with Mayo Clinic Platform and nference to generate these real-world deidentified data from patients seen at the Mayo Clinic Health System. Narcolepsy is a chronic and complex neurological disorder and understanding the most prevalent comorbidities increased in this patient population may help to inform optimal management,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “In contrast to claims-based studies, cardiovascular disease was not among the top 20 co-morbidities found to be increased in the narcolepsy cohort compared to the matched cohort.”

About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients seven years and older with narcolepsy. For more information, please visit www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential impact of the study on helping clinicians optimize the management of patients’ symptoms with the most appropriate treatment. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

About nference
nference is unlocking the potential of healthcare data with AI, delivering real-world evidence, insights, and solutions informed by the most comprehensive multimodal data across all therapeutic areas. Our extensive de-identified, longitudinal data includes decades of clinical notes along with rich patient histories, vitals, lab tests, radiology images, digital pathology, genomics, and electrophysiology waveforms. Our federated data platform, comprised of premier healthcare organizations, including Mayo Clinic, Duke Health, Banner Health, Vanderbilt University Medical Center, and Emory Healthcare, enables advanced research and custom AI model development. With unprecedented access to data from over 40 million patient journeys, our partners can accelerate target discovery, optimize clinical trial design, and enhance lifecycle management. Follow nference on LinkedIn. Visit us at www.nference.com.

Avadel
Investor Contact:
Courtney Mogerley
Precision AQ
Courtney.Mogerley@precisionAQ.com
(212) 698-8687

Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com 
(609) 273-3162

nference
Media Contact:
Andrea Sampson
President/CEO, Sampson Public Relations Group
asampson@sampsonprgroup.com


FAQ

What are the main findings of Avadel's (AVDL) narcolepsy comorbidity study in 2024?

The study found that narcolepsy patients were more likely to have psychiatric, sleep, and pain disorders, with cardiovascular disease notably absent from the top 20 comorbidities, contrasting with previous claims-based studies.

How many patients were included in Avadel's (AVDL) 2024 narcolepsy study?

The study included over 2,000 people with narcolepsy and 2,000 matched controls, analyzing their electronic health data through Mayo Clinic Platform.

What makes Avadel's (AVDL) 2024 narcolepsy study unique?

It is the first real-world study in narcolepsy to use aggregate electronic health record data, providing a more comprehensive view of patient information than claims data alone.

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