AVDL Avadel Pharmaceuticals PLC

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 plcAvadel 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 StatementsThis 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 nferencenference 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.

AvadelInvestor Contact:Courtney MogerleyPrecision AQCourtney.Mogerley@precisionAQ.com(212) 698-8687

Media Contact:Lesley StanleyReal Chemistrylestanley@realchemistry.com (609) 273-3162

nferenceMedia Contact:Andrea SampsonPresident/CEO, Sampson Public Relations Groupasampson@sampsonprgroup.com